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AstraZeneca/Merck's Lynparza Get FDA Nod for Prostate Cancer

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AstraZeneca (AZN - Free Report) and partner Merck (MRK - Free Report) announced that the FDA has approved their PARP inhibitor Lynparza for the fourth cancer type — prostate cancer. The FDA approved Lynparza for the treatment of men with metastatic castration-resistant prostate cancer (mCRPC), who have a mutation in their homologous recombination repair (HRRm) genes. The disease of these men had progressed on prior treatment with new hormonal agent (NHA) treatments like J&J’s Zytiga and Pfizer/Astellas’ Xtandi, making it difficult to treat.

Approval for the expanded indication was based on data from the phase III PROfound study. The data showed that treatment with Lynparza more than doubled the median radiographic progression-free survival and led to a significant and clinically meaningful improvement in overall survival in men with mCRPC selected for BRCA1/2 or ATM gene mutations, a subpopulation of HRR gene mutations, versus Zytiga and Xtandi. Treatment with Lynparza reduced the risk of disease progression or death by 66%.

mCRPC occurs when prostate cancer grows and spreads to the other parts of the body. HRR gene mutations occur in approximately 20-30% of patients with mCRPC. PARP inhibitors, such as Lynparza can target these genes well and the drug could be in high demand for this indication. Lynparza is also under regulatory review for the mCRPC indication in Europe.

Last week, the FDA approved Lynparza in combination with Roche’s Avastin as a maintenance treatment for first-line advanced ovarian cancer in women, who have an HRD-positive tumor. About one in two women with advanced ovarian cancer has an HRD-positive tumor. The approval of Lynparza for the expanded ovarian cancer group was based on data from the phase III PAOLA-1 study.

This year so far, AstraZeneca’s shares have risen 7.9% while Merck’s shares have lost 15.5% against a decrease of 1.5% for the industry.



Lynparza, was until now approved in three tumor types— ovarian, breast and pancreatic and pancreatic cancer is the fourth tumor type for which Lynparza is now approved. Lynparza is being evaluated as a monotherapy and in combination with other drugs in earlier line settings for  these tumor types.

Another PARP inhibitor, Clovis Oncology’s (CLVS - Free Report) Rubraca was also approved by the FDA, earlier this week, to treat BRCA-mutant recurrent, mCRPC in patients treated with androgen receptor-directed therapy and a taxane-based chemotherapy. Other PARP inhibitors available in the market include Glaxo’s (GSK) Zejula and Pfizer’s (PFE - Free Report) Talzenna. Both these drugs are not yet approved for prostate cancer indications.

Lynparza, which is being jointly developed and commercialized by AstraZeneca and Merck, generated product sales of $397 million for AstraZeneca in the first quarter of 2020, and alliance revenues of $145 million for Merck. AstraZeneca will receive $35 million in milestone payment from Merck, following the latest approval for HRR gene-mutated mCRPC.

AstraZeneca currently has a Zacks Rank #2 (Buy) while Merck has a Zacks Rank #3 (Hold).You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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