The FDA has issued approval for Lynparza (olaparib) in the treatment of adult patients with deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC) who have progressed following prior treatment with Xtandi (enzalutamide by Pfizer/Astellas) or Zytiga (abiraterone by Centocor/Johnson & Johnson). HRR gene mutations occur in approximately 20–30% of patients with mCRPC. Lynparza is a poly (ADB ribose) polymerase (PARP) inhibitor. The poly ADP-ribose polymerase (PARP) enzyme fixes DNA damage in both healthy and cancerous cells. Lynparza is available by prescription only and produced in 100mg and 150mg tablet strengths. Read the story and contact John Baresky for further details...

1. … AstraZeneca and Merck Lynparza (olaparib) Gain Another Oncology Indication In Men’s Health …
LYNPARZA (olaparib) GAINS NEW
PROSTATE CANCER INDICATION
AstraZeneca and Merck Collaboration Continues To Pay Off For
Patients, Oncologists, Urologists And Investors
Bare Sky Marketing — Healthcare Content Writing
May 20 · 4 min read
The FDA has issued approval for Lynparza (olaparib) in the treatment of
adult patients with deleterious or suspected deleterious germline or somatic
homologous recombination repair (HRR) gene-mutated metastatic
castration-resistant prostate cancer (mCRPC) who have progressed
following prior treatment with Xtandi (enzalutamide by Pfizer/Astellas) or
Zytiga (abiraterone by Centocor/Johnson & Johnson).

2. HRR gene mutations occur in approximately 20–30% of patients with
mCRPC. Lynparza is a poly (ADB ribose) polymerase (PARP) inhibitor. The
poly ADP-ribose polymerase (PARP) enzyme fixes DNA damage in both
healthy and cancerous cells. Lynparza is available by prescription only and
produced in 100mg and 150mg tablet strengths.
This FDA approval of Lynparza features a requirement for
testing to specifically identify appropriate patients to be
treated based on the indication
Patients will be selected for Lymparza therapy based on two FDA-approved
companion diagnostic tests. FoundationOne CDx, manufactured by
Foundation Medicine, Inc. is for the selection of patients with mCRPC
carrying HRR gene alterations. Founded in 2009, Foundation Medicine is
based in Cambridge, Massachusetts and is a business unit of Roche
Holdings AG (OTTC MKTS: RHHBY) based in Basel, Switzerland.
For the selection of patients with mCRPC carrying germline BRCA1/2
alterations, the FDA has approved the BRACAnalysis CDx test which is
produced by Myriad Genetic Laboratories, Inc. Founded in 1991, Myriad
Genetics (NASDAQ: MYGNQ) is headquartered in Salt Lake City, Utah.
Prostate cancer is a global healthcare challenge
Prostate cancer is a stubborn opponent to the success of patients,
oncologists, urologists and pharmaceutical companies worldwide. It is the
second-most common cancer in men (lung cancer is number one) and while
its fatalities have fallen, there are major hurdles that must be overcome to
realize significantly better results. Despite an increase in the number of
available therapies for patients with mCRPC, the five-year survival rate
remains low.

3. The risk of prostate cancer increases with age, trending upward beginning at
50 years of age with over 80% of newly diagnosed prostate cancer cases
occurring in patients 65 years of age and older. In the United States,
approximately 192,000 persons are diagnosed annually with prostate
cancer according to the Amerian Cancer Society (ACS) and about 34,000
cases are fatal.
Lynparza has more promising potential in oncology
Multiple Lynparza clinical trials are being conducted in metastatic prostate
cancer. One of them involves AstraZeneca and Merck pursuing a first-line
indication through Lynparza’s Phase 3 PROpel trial evaluation when used in
combination with abiraterone acetate for patients with mCRPC vs.
abiraterone acetate alone.
The AstraZeneca and Merck collaboration is a clinically and
commercially successful partnership
The new indication for Lynparza is another successful milestone for the
AstraZeneca (NYSE: AZN) and Merck (NYSE: MRK) tandem. Earlier in
2020, the FDA approved its jointly-developed kinase inhibitor Koselugo
(selumetinib).
Koselugo is indicated for pediatric patients two years of age and up
with neurofibromatosis Type 1 (NF1) who have symptomatic, inoperable
plexiform neurofibromas (PN). This development was especially significant
as Koselugo is the first FDA approved medicine specifically for the treatment
of pediatric NF1 PN which is a rare and serious genetic condition.
Merck generated approximately $47 billion in 2019 sales while
AstraZeneca’s 2019 sales were over $24 billion. Based on the agreement

4. between the two companies, AstraZeneca is the primary commercial sales
arm for the therapies they co-develop and half of the profits go to Merck.
AstraZeneca and Merck established the collaboration in 2017. It is focused
on researching, developing and fully commercializing novel therapeutics
aligned with oncology and associated healthcare issues.
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