LYNPARZA (olaparib) GAINS NEW PROSTATE CANCER INDICATION
AstraZeneca and Merck Collaboration Continues To Pay Off For Patients, Oncologists, Urologists And Investors
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.
Lynparza’s FDA approval 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) headquartered 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. 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.
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 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. Lynparza and Koselugo demonstrate the clinical and commercial attributes that make Merck and AstraZeneca a formidable competitive tandem.
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