Review of novel biological cancer therapies and exploration of ways that would make them locally available within the context of a low-to-middle income EU country. doi: 10.13140/RG.2.2.22894.72002 ARETE-ZOE, as a consultancy, provides solutions to complex problems in the high stakes and high consequence environment of Global Pharmaceuticals, including clinical research, healthcare informatics, and public health.  We blend established, Pharma sector methodologies, innovation, and adaptations/transfers from other sectors to identify and resolve consequential practices that pose risk and often result in avoidable patient casualty. However, we are specifically, not a patient advocacy group but believe in optimizing organizational effectiveness and  that smart business is agile, competitive and profitable, while intrinsically safe, secure, and resilient. We  work within a global context because transnational interests influence national circumstances and choices at point of prescription. ARETE-ZOE, provides full spectrum organizational and operational risk management consultancy. Our published materials provide a glimpse of some aspects of our services to demonstrate both knowledge and ongoing participation within the Pharmaceutical Industry. Our analysis and consultancy includes all channels of misuse, diversion, counterfeiting and illicit exploitation of pharmaceuticals, medical devices, and precursor chemicals. Our advisement is to manufactures, jurisdictional entities, insurers, legislators, litigators, patients, and health care providers. ​ This scope also frequently segues into the nexus of crime and terrorism as significant influencers that undermine sector integrity differentiated from other criminal activity. Obviously, vulnerability assessment, information collection management and intelligence production supporting decision-making for risk reduction and interventions are routinely within the scope of our services as well as design and implementation of operational control measures. 

1. MODERN
ONCOLOGY
THERAPIES
DATE: November 7, 2017
https://www.aretezoe.com/

2. Bottom Line Up Front
• Biological cancer therapies are a major cost-driver
• Precision diagnostics essential for treatment success
• Most biologics used after chemo or in combination with chemo
• Blurred line between research and care
• Quality management and information systems essential
• Continuous evaluation of treatment effectiveness
• Cost-effectiveness a major concern
• Multiple models should be considered for rare cancers
• Access to foreign trials as part of care
• Payment and insurance structure reform
• International exchange of rare cases to EU Centers of Excellence
• Certified CZ centers can become a major source of income
DEFINED STANDARD OF CARE PARAMOUNT
https://www.aretezoe.com/

3. THE MARKET
Registered and Marketed Products
Actual Use – Products issued and reimbursed
https://www.aretezoe.com/

4. Oncology drugs on CZ market
376
166
131
65 64 54 51 50 49
36
0
50
100
150
200
250
300
350
400
imatinib
temozolomide
capecitabine
docetaxel
gemcitabine
bendamustine
irinotecan
paclitaxel
pemetrexed
doxorubicin
epirubicin
everolimus
oxaliplatin
topotecan
bortezomib
mitomycin
carboplatin
cytarabine
etoposide
rituximab
dasatinib
erlotinib
methotrexate
nilotinib
afatinib
axitinib
cabozantinib
ruxolitinib
Ribociclib
vinflunine
vinorelbine
cyclophosphamide
dacarbazine
SUKL ID Count
imatinib 376 10
temozolomide 166 21
capecitabine 131 13
docetaxel 65 14
gemcitabine 64 13
bendamustine 54 12
irinotecan 51 14
paclitaxel 50 14
pemetrexed 49 11
doxorubicin 36 14
Products marketed in Q3
https://www.aretezoe.com/

5. Imatinib
(GLEEVEC)
• Ph+ chronic myeloid leukemia
• Myelodysplastic diseases
• Aggressive systemic mastocytosis (ASM)
• Hypereosinophilic syndrome (HES)
• Chronic eosinophilic leukemia (CEL)
• Dermatofibrosarcoma protuberans (DFSP)
• Gastrointestinal stromal tumors (GIST)
CZ MARKET:
• 376 SUKL IDs registered
• 10 products marketed in Q3 2017
• 0 sold in Q2 2017
• Price range 740 – 7200 USD
• 360 - No price listed
https://www.aretezoe.com/

6. The use of oncology drugs in CZ
0
5,000,000
10,000,000
15,000,000
20,000,000
25,000,000
30,000,000
35,000,000
40,000,000
ANAGRELID
TEMOZOLOMID
VINORELBIN
KAPECITABIN
IBRUTINIB
RUXOLITINIB
HYDROXYMOČOVINA
CHLORAMBUCIL
MERKAPTOPURIN
KLADRIBIN
PONATINIB
PEMBROLIZUMAB
IDELALISIB
ESTRAMUSTIN
FLUDARABIN
MELFALAN
MITOTAN
VENETOKLAX
ERLOTINIB
SORAFENIB
NINTEDANIB
TEGAFUR,KOMBINACE
PALBOCIKLIB
BUSULFAN
NIVOLUMAB
CYKLOFOSFAMID
PAKLITAXEL
LOMUSTIN
VEMURAFENIB
METHYL-AMINOLEVULÁT
TIOGUANIN
BEVACIZUMAB
GEMCITABIN
KARBOPLATINA
METHOTREXÁT
MITOMYCIN
ETOPOSID
BORTEZOMIB
BLEOMYCIN
CISPLATINA
VINKRISTIN
DOXORUBICIN
IXAZOMIB
Oncology drugs sales by API in Q2 2016 (CZK)
Anagrelide Thrombocythemia 35 095 933 Kč 1 587 929 USD
Temozolomide Brain cancer 11 199 645 Kč 506 732 USD
Vinorelbine Lung cancer 10 752 216 Kč 486 488 USD
Capecitabine Breast, gastric and colorectal cancer 8 605 159 Kč 389 344 USD
Ibrutinib B cell cancers 4 455 600 Kč 201 595 USD
Ruxolitinib myelofibrosis and polycythemia vera 2 578 559 Kč 116 668 USD
Hydroxyurea Leukemia, head and neck cancer 2 084 283 Kč 94 304 USD
https://www.aretezoe.com/

7. The use of oncology drugs in CZ7,906
4,975
4,311
4,069
1,853
539
440
227
183
128
85
49
29
29
20
17
17
16
15
14
13
12
10
6
6
6
5
5
5
4
3
3
3
2
2
2
2
2
1
1
1
1
1
0
1,000
2,000
3,000
4,000
5,000
6,000
7,000
8,000
9,000
VINORELBIN
HYDROXYUREA
ANAGRELID
CAPECITABIN
TEMOZOLOMID
CHLORAMBUCIL
MERKAPTOPURIN
ESTRAMUSTIN
MELFALAN
CYKLOFOSFAMID
KLADRIBIN
FLUDARABIN
RUXOLITINIB
IBRUTINIB
GEMCITABIN
MITOTAN
IXAZOMIB
PEMBROLIZUMAB
BUSULFAN
TEGAFUR,COMB
LOMUSTIN
ETOPOSID
PAKLITAXEL
KARBOPLATINA
NIVOLUMAB
METHYL-AMINOLEVULATE
TIOGUANIN
IDELALISIB
VENETOKLAX
ERLOTINIB
DOXORUBICIN
PONATINIB
NINTEDANIB
METHOTREXÁT
VINKRISTIN
CISPLATINA
BEVACIZUMAB
SORAFENIB
BLEOMYCIN
MITOMYCIN
VEMURAFENIB
PALBOCIKLIB
BORTEZOMIB
Number of packages
VINORELBINE Lung cancer 7 906
HYDROXYUREA Leukemia, head and neck cancer 4 975
ANAGRELIDE Thrombocythemia 4 311
CAPECITABINE Breast, gastric and colorectal cancer 4 069
TEMOZOLOMIDE Brain cancer 1 853
CHLORAMBUCIL Leukemia, lymphoma 539
MERCAPTOPURINE Acute lymphatic leukemia 440
ESTRAMUSTINE Prostate cancer 227
MELPHALAN Multiple myeloma, ovarian cancer 183
Products sold in Q2
https://www.aretezoe.com/

8. BURDEN OF DISEASE
Data source: UZIS
Diagnoses: C00-C97
https://www.aretezoe.com/

9. NEOPLASMS in CZ
• Malignancies represent about 25% of all deaths in CZ
• Incidence increasing
• Standardized mortality slightly decreasing
• Highest increase: non-malignant skin neoplasm (non-fatal)
• Most common: prostate (M) and breast (F)
• Most lethal: lung cancer
• 23,000 incapacity (2013)
• 35,400 disability (2013)
https://www.aretezoe.com/

10. Neoplasms (C00-D09) per 100,000 M/F
(2010-2014)
Males Females
https://www.aretezoe.com/

11. Cancer Risk Factors
Smoking
Smoking ban
passed in May
2017 stirred a
major controversy
Obesity
High BMI and
insulin resistance
are linked to
increased risk of
many cancers
Hereditary
High inbreeding
coefficient
increases the risk
of hereditary
cancers
Toxic
Alcohol, asbestos,
environmental
carcinogens
https://www.aretezoe.com/

12. Population age distribution
0
100,000
200,000
300,000
400,000
500,000
600,000
700,000
800,000
900,000
1,000,000
Series1
Series2
Series3
Male
Female
All
UZIS: Novotvary 2015
https://www.aretezoe.com/

13. Neoplasms cases ICD-10 Dg
C00-C97 excl. C44
0
10,000
20,000
30,000
40,000
50,000
60,000
70,000
M
F
Total
UZIS: Novotvary 2015
https://www.aretezoe.com/

14. Incidence: Radiation oncology
Numberofnewcases
Numberofnewcases
per1000persons
Neoplastic diseases
Non-neoplastic diseases
Neoplastic diseases
Non-neoplastic diseases
UZIS: Zdravotnictví ČR: Stručný přehled činnosti oboru
radiační onkologie, klinická onkologie za období 2007–2015
https://www.aretezoe.com/

15. Prevalence: Radiation oncology
Neoplastic diseases
Non-neoplastic diseases
Neoplastic diseases
Non-neoplastic diseases
Numberofnewcases
Numberofnewcases
per1000personsUZIS: Zdravotnictví ČR: Stručný přehled činnosti oboru
radiační onkologie, klinická onkologie za období 2007–2015
https://www.aretezoe.com/

16. Incidence of selected diagnoses
0
2,000
4,000
6,000
8,000
10,000
12,000
14,000
16,000
C16
C18
C19, C20
C23, C24
C25
C32
C33, C34
C43
C44
C50
C61
C64
C67
C91–C95
D37–D48
malignant
neoplasm of skin
Prostate cancer
Lung cancer
UZIS: Novotvary 2015
Colon cancer
https://www.aretezoe.com/

17. Cancer mortality
0
5,000
10,000
15,000
20,000
25,000
30,000
35,000
1994
1995
1996
1997
1998
1999
2000
2001
2002
2003
2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
M
F
Total
0.0
50.0
100.0
150.0
200.0
250.0
300.0
350.0
1994
1995
1996
1997
1998
1999
2000
2001
2002
2003
2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
M
F
Total
UZIS: Novotvary 2015 UZIS: Novotvary 2015
https://www.aretezoe.com/

18. Mortality by diagnosis
0
500
1,000
1,500
2,000
2,500
3,000
3,500
4,000
4,500
5,000
1994199519961997199819992000200120022003200420052006200720082009201020112012201320142015
C16
C18
C19, C20
C23, C24
C25
C32
C33, C34
C43
C44
C50
C61
C64
C67
C91–C95
D37–D48
Lung cancer
Prostate cancer
Colon cancer
UZIS: Novotvary 2015
https://www.aretezoe.com/

19. Lung cancer:
Incidence & mortality
NOR: SVOD
Numberofcasesper100000cases
https://www.aretezoe.com/

20. THE COST OF BIOLOGICAL
CANCER TREATMENTS
TRANSPARENCY | COST-EFFECTIVENESS
https://www.aretezoe.com/

21. Costs
Drivers
Specialized treatment
13.1 billion CZK
(595 million USD)
Cost drivers:
• New facilities
• Number of patients
• Ophthalmology
• Radiation oncology
• Hemodialysis
Oncology therapies
17 billion CZK
(769 million USD)
(VZP 14 billion CZK)
Cost drivers:
Biological treatments
https://www.aretezoe.com/

22. 0 Kč
50,000 Kč
100,000 Kč
150,000 Kč
200,000 Kč
250,000 Kč
300,000 Kč
350,000 Kč
400,000 Kč
Max price manufacturer / Price original (CZK)
Max price manufacturer /
Price original (CZK)
Nominal price for specific packaging regardless cost per treatment
https://www.aretezoe.com/

23. Price of
biological cancer
treatments
Gordon, N., Stemmer, S.,
Greenberg, D. and
Goldstein, D. (2017).
Trajectories of Injectable
Cancer Drug Costs After
Launch in the United
States. Journal of Clinical
Oncology, 35.
Fig 1. Cost trajectories of
targeted therapies.
Cumulative change (%) from
baseline mean monthly cost
by year. General inflation
rates are plotted as black
dotted line; health-related
inflation is plotted as red
dotted line.
https://www.aretezoe.com/

24. Quality
Adjusted
Life
Years
Quality
Adjusted
Disability
Years
In the UK, NICE attempts to control costs by
setting a maximum incremental cost
effectiveness ratio of Ł30 000 per quality
adjusted life year added (QALY)
MeasuresofEffectiveness
https://www.aretezoe.com/

25. Cost-Effectiveness: Colorectal Cancer
Parikh, R., Du, X., Robert, M. and Lairson, D. (2017). Cost-Effectiveness of Treatment Sequences of Chemotherapies and Targeted
Biologics for Elderly Metastatic Colorectal Cancer Patients. Journal of Managed Care and Specialty Pharmacy, 23(1), pp.64-73.
https://www.aretezoe.com/

26. Cost-effectiveness of cancer care
Henry, D. and Taylor, C. (2014). Pharmacoeconomics of Cancer Therapies: Considerations With the Introduction of
Biosimilars. Seminars in Oncology, 41, pp.S13-S20.
https://www.aretezoe.com/

27. DistributionofInsurance
Fig 1. Distribution of (A) patients and (B)
insurance payments by type of chemotherapy
agent from 2001 to 2011. Analysis conducted
using Life-Link Health Plan Claims Database
from January 2001 to September 2011.IV,
intravenous.
Shih, Y., Smieliauskas, F., Geynisman, D., Kelly, R. and Smith,
T. (2015). Trends in the Cost and Use of Targeted Cancer
Therapies for the Privately Insured Nonelderly: 2001 to
2011. Journal of Clinical Oncology, 33(19), pp.2190-2196.
Targeted therapies
dominate anticancer drug
spending.
Payment reform is
necessary, such as
value-based insurance
that makes the benefits
and costs transparent
and accommodates
patients’ choices.
https://www.aretezoe.com/

28. EVIDENCE-BASED
MEDICINE
TRIAL RESULTS | QUALITY OF EVIDENCE
TRANSPARENCY
https://www.aretezoe.com/

29. • Rapidly developing field of medicine
• Molecular level of diagnostics
• High number of treatment protocols
• Multiple sources of data of varying quality
• Clinical trials, most results not available
• Published and unpublished data, publication bias
• Real World Data for the production of Real World Evidence
• Utilization of EHRs and AI systems
• Increasing granularity of outcome reporting
• Frequent changes in response to new evidence
• Data sources
• Evidence appraisal
• Integration of relevant information
• RWD analysis
• Actionable output
Evidenceinoncology
Health Information
Systems involve
significant investment
https://www.aretezoe.com/

30. Significant body of evidence exists
within the domain of oncology
Oncology trials registered in ClinicalTrials.gov
https://www.aretezoe.com/

31. RECRUITING
ONCOLOGY
TRIALS
ClinicalTrials.gov
19,461 Oncology trials
10,287 USA
5,273 Europe
EU Clinical Trials Register
National CT Registry
ClnicalTrials.gov:
Recruiting
Not yet recruiting
Enrolling by invitation
Active, not recruiting
https://www.aretezoe.com/

33. Publication bias
Ben Goldacre, TED Talks

34. StudyEndpoints
https://www.aretezoe.com/

35. StudyEndpoints Patient-centered endpoints
• Overall survival (OS) – Gold standard, difficult to measure
• Health-related quality of life (HR-QOL)
Tumor-centered endpoints
• Used as surrogates for the patient-centered endpoints
• Disease-Free Survival
• Objective Response Rate
• Time to Progression
• Progression-Free Survival
• Time-to-Treatment Failure
Suitability of oncology endpoints varies with the type of tumor, line of
treatment, disease progression, and expected survival.
As patients survive longer, it becomes difficult to
isolate the treatment effects of a single drug because
of the multiple therapeutic protocols they receive
Real World Data are essential to measure
the effectiveness of oncology treatments
https://www.aretezoe.com/

37. CZ National
Oncology
Registry
KSRZIS
National Oncology Registry
• Archival data since 1976
• Oncology centers
Outputs:
• Epidemiological data
• Clinical data
• Treatment effectiveness
NOR - Národní onkologický registr
Evaluation of
treatment
effectiveness
The ability to measure quality of care
and treatment effectiveness is the
foundation of evidence-based medicine
https://www.aretezoe.com/

38. The cost of
healthcare data
________________
Targeted medicines require fast,
accurate and responsive
information systems
Gordon, N., Stemmer, S.,
Greenberg, D. and Goldstein, D.
(2017). Trajectories of
Injectable Cancer Drug Costs
After Launch in the United
States. Journal of Clinical
Oncology, 35.
Fig 2. Cost trajectories of
targeted therapies for metastatic
colon cancer. Cumulative change
(%) from baseline mean monthly
cost by year. General inflation
rates are plotted as black dotted
line; health-related inflation is
plotted as red dotted line.
https://www.aretezoe.com/

39. Rare cancers
• Rare cancers especially rare in small populations
• Limited experience locally
• Rapidly developing field of medicine
• Stove-piping of knowledge and resources
• Integration of research and care
https://www.aretezoe.com/

40. NOVEL
CANCER
THERAPIES
U.S. APPROVED CANCER TREATMENTS 2013-2017
Indications | Availability in CZ | Recruiting trials
https://www.aretezoe.com/

41. abemaciclib
VERZENIO
Eli Lilly
US Approval: 9/2017
CZ: NO
INDICATIONS
HR+, HER2- Advanced metastatic
breast cancer
CLINICAL TRIALS
Global – All 47
Completed 10
Recruiting 25
Recruiting trials in CZ: 2
ClinicalTrials.gov: Recruiting trials
https://www.aretezoe.com/

42. acalabrutinib
CALQUENCE
AstraZeneca
US Approval 10/2017
CZ: NO
INDICATIONS
Mantle Cell Lymphoma
CLINICAL TRIALS
Global – All 29
Completed 1
Recruiting 8
Recruiting trials in CZ: NONE
ClinicalTrials.gov: Recruiting trials
https://www.aretezoe.com/

43. ado-trastuzumab
emtansine
KADCYLA
Genentech
US Approval 2/2013
CZ: NO
INDICATIONS
Metastatic breast cancer
HER2-positive
CLINICAL TRIALS
Global – All 72
Completed 18
Recruiting 30
Recruiting trials in CZ: 3
ClinicalTrials.gov: Recruiting trials
https://www.aretezoe.com/

44. afatinib
GILOTRIF
Boehringer Ingelheim
US Approval 7/2013
CZ: YES
INDICATIONS
EGFR+ non-small cell lung cancer
CLINICAL TRIALS
Global – All 144
Completed 53
Recruiting 45
Recruiting trials in CZ: NONE
ClinicalTrials.gov: Recruiting trials
BRAND in CZ CZK USD
GIOTRIF 49134 $2 223
https://www.aretezoe.com/

45. alectinib
ALECENSA
Hoffmann-LaRoche
US Approval 12/2015
CZ: YES (not reimbursed)
INDICATIONS
Non-small cell lung cancer
CLINICAL TRIALS
Global – All 28
Completed 8
Recruiting 10
Recruiting trials in CZ: NONE
ClinicalTrials.gov: Recruiting trials
New standard of care
for ALK+ NSCLC
BRAND in CZ CZK USD
ALECENSA
Not listed, not reimbursed
ALEKTINIB
Not listed, not reimbursed
https://www.aretezoe.com/

46. atezolizumab
TECENTRIQ
Genentech Oncology
US Approval 10/2016
CZ: NO
INDICATIONS
Non-small cell lung cancer
Urothelial carcinoma
CLINICAL TRIALS
Global – All 198
Completed 2
Recruiting 120
Recruiting trials in CZ: 9
ClinicalTrials.gov: Recruiting trials
https://www.aretezoe.com/

47. avelumab
BAVENCIO
Serono, Inc.
US Approval 5/2017
CZ: YES (not reimbursed)
INDICATIONS
Advanced/metastatic
urothelial carcinoma
CLINICAL TRIALS
Global – All 78
Completed 0
Recruiting 43
Recruiting trials in CZ: 4
ClinicalTrials.gov: Recruiting trials
BRAND in CZ CZK USD
AVELUMAB
Not listed, not reimbursed
BAVENCIO
Not listed, not reimbursed
https://www.aretezoe.com/

48. axicabtagene
ciloleucel
YESCARTA
Kite Pharma, Inc.
US Approval 10/2017
CZ: NO
INDICATIONS
B-cell lymphoma
Diffuse Large B-Cell Lymphoma
CLINICAL TRIALS
Global – All 2
Completed 0
Recruiting 1
Recruiting trials in CZ: NONE
”A CD19-directed genetically modified autologous T cell
immunotherapy indicated for the treatment of adult
patients with relapsed or refractory large B-cell
lymphoma” (FDA, 2017)
ClinicalTrials.gov: Recruiting trials
https://www.aretezoe.com/

49. belinostat
BELEODAQ
Spectrum Pharmaceuticals, Inc.
US Approval 7/2014
CZ: NO
INDICATIONS
Refractory peripheral T-cell
lymphoma
CLINICAL TRIALS
Global – All 42
Completed 25
Recruiting 5
Recruiting trials in CZ: NONE
Beleodaq is a histone deacetylase inhibitor indicated for
the treatment of patients with relapsed or refractory
peripheral T-cell lymphoma (PTCL). This indication is
approved under accelerated approval based on tumor
response rate and duration of response. An
improvement in survival or disease-related symptoms
has not been established. FDA 2014
ClinicalTrials.gov: Recruiting trials
https://www.aretezoe.com/

50. bevacizumab
AVASTIN
Genentech, Inc.
US Approval 1/2013
CZ: YES
CLINICAL TRIALS
Global – All 2,220
Completed 1,071
Recruiting 294
INDICATIONS
• Metastatic colorectal cancer
• Non-squamous non-small cell lung cancer
• Glioblastoma
• Metastatic renal cell carcinoma
• Cervical cancer
• Ovarian, fallopian tube, or peritoneal cancer
Recruiting trials in CZ: 13
ClinicalTrials.gov: Recruiting trials
BRAND in CZ CZK USD
AVASTIN 26 586 Kč $1 203
AVASTIN 7 109 Kč $322
https://www.aretezoe.com/

51. blinatumomab
BLINCYTO
Amgen Inc.
US Approval 7/2017
CZ: YES (not reimbursed)
INDICATIONS
Refractory B-cell precursor Acute
Lymphoblastic Leukemia
CLINICAL TRIALS
Global – All 41
Completed 7
Recruiting 26
Recruiting trials in CZ: 2
ClinicalTrials.gov: Recruiting trials
BRAND in CZ CZK USD
BLINCYTO Not listed, not reimbursed
https://www.aretezoe.com/

52. brentuximab vedotin
ADCETRIS
Seattle Genetics, Inc.
US Approval 8/2015
CZ: YES
INDICATIONS
Auto-Hematopoietic Stem Cell
Transplant for classical Hodgkin
lymphoma at high risk of progression
CLINICAL TRIALS
Global – All 120
Completed 19
Recruiting 46
Recruiting trials in CZ: 6
ClinicalTrials.gov: Recruiting trials
BRAND in CZ CZK USD
ADCETRIS Not listed, not reimbursed
https://www.aretezoe.com/

53. brigatinib
ALUNBRIG
ARIAD Pharmaceuticals, Inc.
US Approval 4/2017
CZ: NO
INDICATIONS
ALK+ non-small cell lung
carcinoma
CLINICAL TRIALS
Global – All 6
Completed 0
Recruiting 2
Recruiting trials in CZ: 1
ClinicalTrials.gov: Recruiting trials
https://www.aretezoe.com/

54. cabazitaxel
JEVTANA
Sanofi Aventis
US Approval 9/2017
CZ: YES
INDICATIONS
Metastatic castration-resistant
prostate cancer
CLINICAL TRIALS
Global – All 103
Completed 41
Recruiting 28
Recruiting trials in CZ: 1
ClinicalTrials.gov: Recruiting trials
BRAND in CZ CZK USD
JEVTANA 102 110 Kč $4 620
https://www.aretezoe.com/

55. cabozantinib
CABOMETYX
Exelixis, Inc.
US Approval 4/2016
CZ: YES (Not reimbursed)
INDICATIONS
Advanced renal cell carcinoma
CLINICAL TRIALS
Global – All 82
Completed 19
Recruiting 24
Recruiting trials in CZ: 2
BRAND in CZ CZK USD
CABOMETYX Not listed, not reimbursed
COMETRIQ Not listed, not reimbursed
ClinicalTrials.gov: Recruiting trials
https://www.aretezoe.com/

56. carfilzomib
KYPROLIS
Onyx Pharmaceuticals, subsidiary
of Amgen, Inc.
US Approval 7/2015
CZ: YES
INDICATIONS
Relapsed multiple myeloma
CLINICAL TRIALS
Global – All 149
Completed 32
Recruiting 56
Recruiting trials in CZ: 1
ClinicalTrials.gov: Recruiting trials
BRAND in CZ CZK USD
KYPROLIS 30 077 Kč $1 361
15 635 Kč $707
5 212 Kč $235
https://www.aretezoe.com/

57. ceritinib
ZYKADIA
Novartis Pharmaceuticals Corp.
US Accelerated Approval 4/2014
US Approval 5/2017
CZ: YES (not reimbursed)
INDICATIONS
ALK+ non-small cell lung carcinoma
CLINICAL TRIALS
Global – All 37
Completed 6
Recruiting 19
Recruiting trials in CZ: 2
ClinicalTrials.gov: Recruiting trials
BRAND in CZ CZK USD
ZYKADIA Not listed, not reimbursed
https://www.aretezoe.com/

58. cobimetinib
COTELLIC
Genentech, Inc.
US Approval 11/2015
CZ: YES (not reimbursed)
INDICATIONS
BRAF V600E or V600K metastatic melanoma
CLINICAL TRIALS
Global – All 67
Completed 11
Recruiting 37
Recruiting trials in CZ: 2 ClinicalTrials.gov: Recruiting trials
BRAND in CZ CZK USD
COTELLIC Not listed, not reimbursed
https://www.aretezoe.com/

59. copanlisib
ALIQOPA
Bayer Healthcare Pharmaceuticals, Inc.
US Accelerated Approval 9/2017
CZ: NO
INDICATIONS
Relapsed follicular lymphoma
CLINICAL TRIALS
Global – All 21
Completed 6
Recruiting 9
Recruiting trials in CZ: 1
ClinicalTrials.gov: Recruiting trials
https://www.aretezoe.com/

60. crizotinib
XALKORI
Pfizer, Inc.
US Approval 11/2013
CZ: YES
INDICATIONS
Metastatic ALK+ or ROS1+
Non-Small Cell Lung Carcinoma
CLINICAL TRIALS
Global – All 119
Completed 23
Recruiting 45
Recruiting trials in CZ: 1
ClinicalTrials.gov: Recruiting trials
BRAND in CZ CZK USD
XALKORI 103 847 Kč $4 699
129 477 Kč $5 859
https://www.aretezoe.com/

61. dabrafenib
TAFINLAR
GlaxoSmithKline, LLC
US Approval 5/2013
CZ: YES
INDICATIONS
BRAF V600E metastatic melanoma
CLINICAL TRIALS
Global – All 93
Completed 21
Recruiting 39
Recruiting trials in CZ: 3
ClinicalTrials.gov: Recruiting trials
BRAND in CZ CZK USD
TAFINLAR 27 855 Kč $1 260
173 516 Kč $7 851
115 677 Kč $5 234
41 783 Kč $1 891
https://www.aretezoe.com/

62. daratumumab
DARZALEX
Janssen Biotech, Inc.
US Approval 11/2016
CZ: YES (not reimbursed)
INDICATIONS
Multiple myeloma
CLINICAL TRIALS
Global – All 74
Completed 3
Recruiting 39
Recruiting trials in CZ: 3
ClinicalTrials.gov: Recruiting trials
BRAND in CZ CZK USD
DARZALEX Not listed, not reimbursed
https://www.aretezoe.com/

63. denosumab
XGEVA
Amgen, Inc.
US Approval 6/2013
CZ: NO
INDICATIONS
Giant cell tumor of bone
CLINICAL TRIALS
Global – All 152
Completed 69
Recruiting 46
Recruiting trials in CZ: 3 ClinicalTrials.gov: Recruiting trials
https://www.aretezoe.com/

64. dinutuximab
UNITUXIN
United Therapeutics Corporation
US Approval 3/2015
CZ: YES (not reimbursed)
INDICATIONS
High-risk neuroblastoma in children
CLINICAL TRIALS
Global – All 23
Completed 6
Recruiting 6
Recruiting trials in CZ: NONE
ClinicalTrials.gov: Recruiting trials
BRAND in CZ CZK USD
DINUTUXIMAB BETA
APEIRON
Not listed, not reimbursed
https://www.aretezoe.com/

65. durvalumab
IMFINZI
AstraZeneca UK
US Accelerated Approval 5/2017
CZ: NO
INDICATIONS
Advanced or metastatic
urothelial carcinoma
CLINICAL TRIALS
Global – All 212
Completed 5
Recruiting 130
Recruiting trials in CZ: NONE
ClinicalTrials.gov: Recruiting trials
https://www.aretezoe.com/

66. elotuzumab
EMPLICITI
Bristol-Myers Squibb Co.
US Approval 11/2015
CZ: YES (Not reimbursed)
INDICATIONS
Multiple myeloma
CLINICAL TRIALS
Global – All 44
Completed 9
Recruiting 14
Recruiting trials in CZ: 3
ClinicalTrials.gov: Recruiting trials
BRAND in CZ CZK USD
EMPLICITI Not listed, not reimbursed
https://www.aretezoe.com/

67. enasidenib
IDHIFA
Celgene Corp.
US Approval 8/2017
CZ: NO
INDICATIONS
IDH2+ refractory acute myeloid
leukemia
CLINICAL TRIALS
Global – All 3
Completed 0
Recruiting 2
Recruiting trials in CZ: NONE
ClinicalTrials.gov: Recruiting trials
https://www.aretezoe.com/

68. eribulin
HALAVEN
Eisai Co Ltd
US Approval 1/2016
CZ: YES
INDICATIONS
Metastatic liposarcoma
CLINICAL TRIALS
Global – All 136
Completed 52
Recruiting 40
Recruiting trials in CZ: NONE
ClinicalTrials.gov: Recruiting trials
BRAND in CZ CZK USD
HALAVEN 8 706 Kč $394
ERLOTINIB MYLAN Not listed, not reimbursed
ERLOTINIB TEVA Not listed, not reimbursed
TARCEVA 44 836 Kč $2 029
TARCEVA 36 156 Kč $1 636
https://www.aretezoe.com/

69. erlotinib
TARCEVA
Astellas Pharma
US Approval 5/2013
US modified indication 10/2016
CZ: YES
INDICATIONS
EGFR+ Non-Small Cell Lung
Carcinoma
CLINICAL TRIALS
Global – All 854
Completed 459
Recruiting 92
Recruiting trials in CZ: 2
ClinicalTrials.gov: Recruiting trials
BRAND in CZ CZK USD
ERLOTINIB MYLAN Not listed, not reimbursed
ERLOTINIB TEVA Not listed, not reimbursed
TARCEVA 44 836 Kč $2 029
36 156 Kč $1 636
https://www.aretezoe.com/

70. everolimus
AFINITOR
Novartis
US Approval 2/2016
CZ: YES
INDICATIONS
Non-functional neuroendocrine tumors
of gastrointestinal or lung origin
CLINICAL TRIALS
Global – All 2104
Completed 941
Recruiting 360
Recruiting trials in CZ: 4
ClinicalTrials.gov: Recruiting trials
BRAND in CZ CZK USD
EVEROLIMUS TEVA Not listed, not reimbursed
VOTUBIA Not listed, not reimbursed
AFINITOR 81 952 Kč $3 708
57 978 Kč $2 623
https://www.aretezoe.com/

71. gefitinib
IRESSA
AstraZeneca
US Approval 7/2015
CZ: YES
INDICATIONS
Non-Small Cell Lung
Carcinoma with EGFR 19
deletion or exon 21 (L858R)
subst. mutation
CLINICAL TRIALS
Global – All 400
Completed 212
Recruiting 45
Recruiting trials in CZ: NONE
ClinicalTrials.gov: Recruiting trials
BRAND in CZ CZK USD
IRESSA 50 395 Kč $2 280
50 395 Kč $2 280
https://www.aretezoe.com/

72. gemtuzumab
ozogamicin
MYLOTARG
Pfizer, Inc.
US Approval 9/2017
CZ: NO
INDICATIONS
CD33+ Acute Myeloid Leukemia
CLINICAL TRIALS
Global – All 74
Completed 47
Recruiting 7
Recruiting trials in CZ: NONE
ClinicalTrials.gov: Recruiting trials
https://www.aretezoe.com/

73. idelalisib
ZYDELIG
Gilead Sciences, Inc.
US Approval 7/2014
CZ: YES (not reimbursed)
INDICATIONS
Chronic lymphocytic leukemia
CLINICAL TRIALS
Global – All 54
Completed 16
Recruiting 8
Recruiting trials in CZ: 3
ClinicalTrials.gov: Recruiting trials
BRAND in CZ CZK USD
ZYDELIG Not listed, not reimbursed
https://www.aretezoe.com/

74. inotuzumab
ozogamicin
BESPONSA
Wyeth Pharmaceuticals, Inc.
US Approval 8/2017
CZ: YES (Not reimbursed)
INDICATIONS
Refractory B-cell precursor
acute lymphoblastic leukemia
CLINICAL TRIALS
Global – All 25
Completed 10
Recruiting 8
Recruiting trials in CZ: NONE
ClinicalTrials.gov: Recruiting trials
BRAND in CZ CZK USD
BESPONSA Not listed, not reimbursed
INOTUZUMAB OZOGAMICIN Not listed, not reimbursed
https://www.aretezoe.com/

75. ipilimumab
YERVOY
Bristol-Myers Squibb Co.
US Approval 10/2015
CZ: YES
INDICATIONS
Cutaneous melanoma
CLINICAL TRIALS
Global – All 420
Completed 78
Recruiting 187
Recruiting trials in CZ: 12
ClinicalTrials.gov: Recruiting trials
BRAND in CZ CZK USD
YERVOY 371 718 Kč $16 820
92 929 Kč $4 205
https://www.aretezoe.com/

76. ixazomib
NINLARO
Takeda Pharmaceuticals
US Approval 11/2015
CZ: YES (Not reimbursed)
INDICATIONS
Multiple myeloma
CLINICAL TRIALS
Global – All 92
Completed 9
Recruiting 54
Recruiting trials in CZ: 3
ClinicalTrials.gov: Recruiting trials
BRAND in CZ CZK USD
NINLARO Not listed, not reimbursed
https://www.aretezoe.com/

77. lanreotide
SOMATULINE
Ipsen Pharma
US Approval 12/2014
CZ: NO
INDICATIONS
Locally advanced or metastatic
gastroenteropancreatic neuroendocrine
tumors (GEP-NETs)
CLINICAL TRIALS
Global – All 93
Completed 47
Recruiting 21
Recruiting trials in CZ: 1
ClinicalTrials.gov: Recruiting trials
https://www.aretezoe.com/

78. lenalidomide
REVLIMID
Celgene Corp.
US Approval 6/2013 (MCL)
US Approval 2/2017 (MM)
CZ: NO
INDICATIONS
Multiple myeloma
Mantle cell lymphoma
CLINICAL TRIALS
Global – All 785
Completed 248
Recruiting 164
Recruiting trials in CZ: 2
ClinicalTrials.gov: Recruiting trials
https://www.aretezoe.com/

79. lenvatinib
LENVIMA
Eisai, Inc.
US Approval 2/2015 (Th)
US Approval 5/2016 (RCC)
CZ: YES (not reimubursed)
INDICATIONS
Thyroid cancer
Renal cell carcinoma
CLINICAL TRIALS
Global – All 67
Completed 21
Recruiting 24
Recruiting trials in CZ: 2
ClinicalTrials.gov: Recruiting trials
BRAND in CZ CZK USD
KISPLYX Not listed, not reimbursed
LENVIMA Not listed, not reimbursed
https://www.aretezoe.com/

80. mercaptopurine
PURIXAN
NOVA Laboratories
US Approval 4/2014
CZ: YES
INDICATIONS
Acute lymphoblastic leukemia (ALL)
CLINICAL TRIALS
Global – All 224
Completed 95
Recruiting 54
Recruiting trials in CZ: NONE ClinicalTrials.gov: Recruiting trials
BRAND in CZ CZK USD
XALUPRINE Not listed, not reimbursed
PURI-NETHOL 1 546 Kč $70
https://www.aretezoe.com/

81. midostaurin
RYDAPT
Novartis Pharmaceuticals
US Approval 4/2017
CZ: YES (not reimbursed)
INDICATIONS
FLT3+ Acute Myeloid
Leukemia
CLINICAL TRIALS
Global – All 31
Completed 7
Recruiting 8
Recruiting trials in CZ: 1
ClinicalTrials.gov: Recruiting trials
BRAND in CZ CZK USD
MIDOSTAURIN (PKC412) Not listed, not reimbursed
RYDAPT Not listed, not reimbursed
https://www.aretezoe.com/

82. necitumumab
PORTRAZZA
Eli Lilly
US Approval 11/2015
CZ: YES (not reimbursed)
INDICATIONS
Metastatic squamous non-small
cell lung cancer
CLINICAL TRIALS
Global – All 18
Completed 6
Recruiting 4
Recruiting trials in CZ: NONE
ClinicalTrials.gov: Recruiting trials
BRAND in CZ CZK USD
PORTRAZZA Not listed, not reimbursed
https://www.aretezoe.com/

83. neratinib
NERLYNX
Puma Biotechnology
US Approval 7/2017
CZ: NO
INDICATIONS
HER2-overexpressed/amplified
breast cancer
CLINICAL TRIALS
Global – All 51
Completed 21
Recruiting 11
Recruiting trials in CZ: 2
ClinicalTrials.gov: Recruiting trials
https://www.aretezoe.com/

84. niraparib
ZEJULA
Tesaro, Inc.
US Approval 3/2017
CZ: NO
INDICATIONS
Epithelial ovarian, Fallopian
tube, or primary peritoneal
cancer
CLINICAL TRIALS
Global – All 28
Completed 3
Recruiting 10
Recruiting trials in CZ: 1
ClinicalTrials.gov: Recruiting trials
https://www.aretezoe.com/

85. nivolumab
OPDIVO
Bristol-Myers Squibb Co.
US Approval 12/2014
CZ: YES
INDICATIONS
Hepatocellular carcinoma
dMMR and MSI-H metastatic colorectal cancer
Metastatic urothelial carcinoma
Metastatic squamous cell carcinoma
Renal cell carcinoma
Metastatic melanoma
Non-small cell lung cancer
Classical Hodgkin lymphoma
CLINICAL TRIALS
Global – All 529
Completed 9
Recruiting 349
Recruiting trials in CZ: 21
ClinicalTrials.gov: Recruiting trials
BRAND in CZ CZK USD
NIVOLUMAB (BMS-936558) Not listed, not reimbursed
OPDIVO 36 040 Kč $1 631
14 422 Kč $653
https://www.aretezoe.com/

86. obinutuzumab
GAZYVA
Genentech, Inc.
US Approval 11/2013 (FL)
US Approval 2/2016 (CLL)
CZ: YES
INDICATIONS
Follicular lymphoma
Chronic lymphocytic leukemia
CLINICAL TRIALS
Global – All 110
Completed 10
Recruiting 56
Recruiting trials in CZ: 4
ClinicalTrials.gov: Recruiting trials
BRAND in CZ CZK USD
GAZYVARO 104 663 Kč $4 736
https://www.aretezoe.com/

87. ofatumumab
ARZERRA
Novartis Pharmaceuticals
US Approval 4/2014
CZ: YES (not reimbursed)
INDICATIONS
Chronic lymphocytic leukemia
CLINICAL TRIALS
Global – All 117
Completed 43
Recruiting 16
Recruiting trials in CZ: 6
ClinicalTrials.gov: Recruiting trials
BRAND in CZ CZK USD
ARZERRA Not listed, not reimbursed
https://www.aretezoe.com/

88. olaparib
LYNPARZA
AstraZeneca
US Approval 12/2014
CZ: YES (not reimbursed)
INDICATIONS
gBRCAm ovarian cancer
Epithelial ovarian, fallopian tube, and
primary peritoneal cancer
CLINICAL TRIALS
Global – All 155
Completed 23
Recruiting 74
Recruiting trials in CZ: 3 ClinicalTrials.gov: Recruiting trials
BRAND in CZ CZK USD
LYNPARZA Not listed, not reimbursed
https://www.aretezoe.com/

89. olaratumab
LARTRUVO
Eli Lilly
US Approval 10/2016
CZ: YES (not reimbursed)
INDICATIONS
Soft-tissue sarcoma
CLINICAL TRIALS
Global – All 17
Completed 5
Recruiting 7
Recruiting trials in CZ: NONE
ClinicalTrials.gov: Recruiting trials
BRAND in CZ CZK USD
LARTRUVO Not listed, not reimbursed
https://www.aretezoe.com/

90. osimertinib
TAGRISSO
AstraZeneca
US Approval 11/2015
CZ: YES (not reimbursed)
INDICATIONS
EGFR T790M non-small cell
lung cancer
CLINICAL TRIALS
Global – All 63
Completed 7
Recruiting 28
Recruiting trials in CZ: NONE
ClinicalTrials.gov: Recruiting trials
BRAND in CZ CZK USD
TAGRISSO Not listed, not reimbursed
https://www.aretezoe.com/

91. paclitaxel protein-bound
particles (albumin-bound)
ABRAXANE
Abraxis BioScience, LLC,
subsidiary of Celgene Corp.
US Approval 9/2013
CZ: YES (not reimbursed)
INDICATIONS
Metastatic adenocarcinoma
of the pancreas
CLINICAL TRIALS
Global – All 1971
Completed 862
Recruiting 342
Recruiting trials in CZ: NONE
ClinicalTrials.gov: Recruiting trials
BRAND in CZ CZK USD
ABRAXANE Not listed, not reimbursed
https://www.aretezoe.com/

92. palbociclib
IBRANCE
Pfizer, Inc.
US Approval 2/2015
CZ: YES (not reimbursed)
INDICATIONS
HR+, HER2- metastatic breast cancer
CLINICAL TRIALS
Global – All 146
Completed 29
Recruiting 76
Recruiting trials in CZ: 2
ClinicalTrials.gov: Recruiting trials
BRAND in CZ CZK USD
IBRANCE Not listed, not reimbursed
https://www.aretezoe.com/

93. panobinostat
FARYDAK
Novartis Pharmaceuticals
US Approval 2/2015
CZ: YES (not reimbursed)
INDICATIONS
Multiple myeloma
CLINICAL TRIALS
Global – All 138
Completed 59
Recruiting 12
Recruiting trials in CZ: 1
ClinicalTrials.gov: Recruiting trials
BRAND in CZ CZK USD
FARYDAK Not listed, not reimbursed
https://www.aretezoe.com/

94. pembrolizumab
KEYTRUDA
Merck & Co. Inc.
US Approval 9/2014
CZ YES (not reimbursed)
INDICATIONS
PD-L1+ Gastric or gastroesophageal junction
carcinoma
MSI-H or dMMR solid tumors, colorectal cancer
Urothelial carcinoma
Non-squamous non-small cell lung carcinoma
Classical Hodgkin lymphoma
Head and neck squamous cell carcinoma
Metastatic melanoma
CLINICAL TRIALS
Global – All 642
Completed 5
Recruiting 411
Recruiting trials in CZ: 11
ClinicalTrials.gov: Recruiting trials
BRAND in CZ CZK USD
KEYTRUDA Not listed, not reimbursed
https://www.aretezoe.com/

95. pertuzumab
PERJETA
Genentech, Inc.
US Approval 9/2013
CZ: YES (not reimbursed)
INDICATIONS
HER2+ locally advanced, inflammatory or
early stage breast cancer
CLINICAL TRIALS
Global – All 140
Completed 34
Recruiting 52
Recruiting trials in CZ: 2
ClinicalTrials.gov: Recruiting trials
BRAND in CZ CZK USD
PERJETA Not listed, not reimbursed
https://www.aretezoe.com/

96. pomalidomide
POMALYST
Celgene Corp.
US Accelerated Approval 2/2013
CZ: NO
INDICATIONS
Multiple myeloma
CLINICAL TRIALS
Global – All 139
Completed 30
Recruiting 40
Recruiting trials in CZ: 6
ClinicalTrials.gov: Recruiting trials
https://www.aretezoe.com/

97. ponatinib
ICLUSIG
ARIAD Pharmaceuticals
US Approval 2012
CZ: YES (not reimbursed)
INDICATIONS
chronic myeloid leukemia
Philadelphia chromosome–positive acute
lymphoblastic leukemia
T315I-positive chronic myeloid leukemia
CLINICAL TRIALS
Global – All 35
Completed 3
Recruiting 16
Recruiting trials in CZ: 3
ClinicalTrials.gov: Recruiting trials
BRAND in CZ CZK USD
ICLUSIG Not listed, not reimbursed

98. ramucirumab
CYRAMZA
Eli Lilly
US Approval 4/2014
CZ: YES (not reimbursed)
INDICATIONS
Metastatic colorectal cancer
Metastatic non-small cell lung
carcinoma
Gastroesophageal junction (GEJ)
carcinoma
CLINICAL TRIALS
Global – All 82
Completed 31
Recruiting 24
Recruiting trials in CZ: 4
ClinicalTrials.gov: Recruiting trials
BRAND in CZ CZK USD
CYRAMZA Not listed, not reimbursed
https://www.aretezoe.com/

99. regorafenib
STIVARGA
Bayer HealthCare Pharmaceuticals Inc.
US Approval 4/2017
CZ: YES
INDICATIONS
Hepatocellular carcinoma
CLINICAL TRIALS
Global – All 131
Completed 23
Recruiting 46
Recruiting trials in CZ: 4
ClinicalTrials.gov: Recruiting trials
BRAND in CZ CZK USD
STIVARGA 59 355 Kč $2 686
https://www.aretezoe.com/

100. ribociclib
KISQALI
Novartis Pharmaceuticals
US Approval 3/2017
CZ: YES (not reimbursed)
INDICATIONS
HR-, HER2+ advanced/metastatic breast cancer
CLINICAL TRIALS
Global – All 70
Completed 5
Recruiting 43
Recruiting trials in CZ: 3
ClinicalTrials.gov: Recruiting trials
BRAND in CZ CZK USD
KISQALI Not listed, not reimbursed
https://www.aretezoe.com/

101. rucaparib
RUBRACA
Clovis Oncology
Genentech, Inc.
US Approval 12/2016
CZ: NO
INDICATIONS
BRCA+ ovarian cancer
CLINICAL TRIALS
Global – All 17
Completed 3
Recruiting 7
Recruiting trials in CZ: 1
ClinicalTrials.gov: Recruiting trials
https://www.aretezoe.com/

102. siltuximab
SYLVANT
Janssen Biotech, Inc.
US Approval 4/2014
CZ: NO
INDICATIONS
Multicentric Castleman’s
Disease
CLINICAL TRIALS
Global – All 24
Completed 11
Recruiting 2
Recruiting trials in CZ: NONE
ClinicalTrials.gov: Recruiting trials
https://www.aretezoe.com/

103. sonidegib
ODOMZO
Novartis Pharmaceuticals
US Approval 7/2015
CZ: YES (not reimbursed)
INDICATIONS
Locally advanced basal cell
carcinoma
CLINICAL TRIALS
Global – All 38
Completed 16
Recruiting 2
Recruiting trials in CZ: NONE
ClinicalTrials.gov: Recruiting trials
BRAND in CZ CZK USD
ODOMZO Not listed, not reimbursed
https://www.aretezoe.com/

104. sorafenib
NEXAVAR
Bayer Healthcare Pharmaceuticals
US Approval 11/2013
CZ: YES
INDICATIONS
Metastatic, progressive differentiated
thyroid carcinoma
CLINICAL TRIALS
Global – All 773
Completed 356
Recruiting 123
Recruiting trials in CZ: 5
ClinicalTrials.gov: Recruiting trials
BRAND in CZ CZK USD
NEXAVAR 79 623 Kč $3 603
https://www.aretezoe.com/

105. talimogene
laherparepvec
IMLYGIC
Amgen Inc
US Approval 10/2015
CZ: YES (not reimbursed)
INDICATIONS
Melanoma
CLINICAL TRIALS
Global – All 32
Completed 5
Recruiting 17
Recruiting trials in CZ: 1
ClinicalTrials.gov: Recruiting trials
BRAND in CZ CZK USD
IMLYGIC Not listed, not reimbursed
https://www.aretezoe.com/

106. tisagenlecleucel
KYMRIAH
Novartis Pharmaceuticals
US Approval 8/2017
CZ: NO
INDICATIONS
B-cell precursor acute
lymphoblastic leukemia
CLINICAL TRIALS
Global – All 1
Completed 0
Recruiting 1
Recruiting trials in CZ: NONE
ClinicalTrials.gov: Recruiting trials
https://www.aretezoe.com/

107. trabectedin
YONDELIS
Janssen
US Approval 10/2015
CZ: YES (not reimbursed)
INDICATIONS
Metastatic liposarcoma
Leiomyosarcoma
CLINICAL TRIALS
Global – All 75
Completed 31
Recruiting 22
Recruiting trials in CZ: NONE
ClinicalTrials.gov: Recruiting trials
BRAND in CZ CZK USD
YONDELIS Not listed, not reimbursed
MEKINIST Not listed, not reimbursed
https://www.aretezoe.com/

108. trametinib
MEKINIST
GlaxoSmithKline
US Approval 5/2013
CZ: YES (not reimbursed)
INDICATIONS
BRAF V600E or V600K metastatic melanoma
CLINICAL TRIALS
Global – All 144
Completed 34
Recruiting 52
Recruiting trials in CZ: 3
ClinicalTrials.gov: Recruiting trials
BRAND in CZ CZK USD
TRAMETINIB Not listed, not reimbursed

109. venetoclax
VENCLEXTA
AbbVie Inc. and Genentech USA, Inc.
US Approval 4/2016
CZ: YES (not reimbursed)
INDICATIONS
Chronic lymphocytic leukemia
CLINICAL TRIALS
Global – All 76
Completed 3
Recruiting 39
Recruiting trials in CZ: 3
ClinicalTrials.gov: Recruiting trials
BRAND in CZ CZK USD
VENCLYXTO Not listed, not reimbursed
https://www.aretezoe.com/

110. ARETE-ZOE, as a consultancy, provides solutions to complex
problems in the high stakes and high consequence environment of
Global Pharmaceuticals, including clinical research, healthcare
informatics, and public health. We blend established, Pharma sector
methodologies, innovation, and adaptations/transfers from other
sectors to identify and resolve consequential practices that pose risk
and often result in avoidable patient casualty. However, we
are specifically, not a patient advocacy group but believe in optimizing
organizational effectiveness and that smart business is agile,
competitive and profitable, while intrinsically safe, secure, and
resilient. We work within a global context because transnational
interests influence national circumstances and choices at point of
prescription.
ARETE-ZOE, provides full spectrum organizational and operational
risk management consultancy. Our published materials provide a
glimpse of some aspects of our services to demonstrate both
knowledge and ongoing participation within the Pharmaceutical
Industry. Our analysis and consultancy includes all channels of
misuse, diversion, counterfeiting and illicit exploitation of
pharmaceuticals, medical devices, and precursor chemicals. Our
advisement is to manufactures, jurisdictional entities, insurers,
legislators, litigators, patients, and health care providers.
This scope also frequently segues into the nexus of crime and
terrorism as significant influencers that undermine sector integrity
differentiated from other criminal activity. Obviously, vulnerability
assessment, information collection management and intelligence
production supporting decision-making for risk reduction and
interventions are routinely within the scope of our services as well as
design and implementation of operational control measures.
https://www.aretezoe.com/