Clovis Oncology, Inc. (CLVS - Free Report) announced that the FDA has granted accelerated approval to a supplemental new drug application (sNDA) seeking label expansion of its sole marketed drug, Rubraca, beyond ovarian cancer. The sNDA was seeking label expansion for the PARP inhibitor as a monotherapy for BRCA-mutant recurrent, metastatic castrate-resistant prostate cancer (mCRPC) in patients treated with androgen receptor-directed therapy and a taxane-based chemotherapy.
Rubraca is also approved as second-line maintenance treatment for ovarian cancer and as monotherapy for BRCA-mutant ovarian cancer in third or later-line setting.
Shares of Clovis have declined 58.5% in the past year compared with the industry’s decrease of 1.3%.
The sNDA was filed based on data from a phase II TRITON2 study. Data from the phase II TRITON2 study demonstrated that mCRPC patients with BRCA mutation treated with Rubraca achieved 44% confirmed objective response rate. Moreover, 55% of the eligible patients achieved confirmed prostate-specific antigen response.
The company is conducting a confirmatory study — TRITON 3 — to support the continued approval for Rubraca for mCRPC patients. Clovis is currently enrolling patients in the phase III study, which is evaluating Rubraca in mCRPC patients with BRCA mutation and ATM mutation. The primary endpoint of the study is radiographic progression-free survival (rPFS).
The approval of Rubraca to include mCRPC patients is likely to put the drug ahead of its competitor as there no other approved PARP inhibitor for treating prostate cancer. Meanwhile, AstraZeneca and Merck’s (MRK - Free Report) regulatory application for their PARP inhibitor, Lynparza, is under review in the United States. The application seeks label expansion for Lynparza for metastatic castration-resistant prostate cancer (with HRR genetic mutations). A decision is expected in this quarter.
Meanwhile, competition for Clovis from large pharma companies in the PARP inhibitor segment is rising with availability of other PARP inhibitors including Glaxo’s (GSK - Free Report) Zejula and Pfizer’s (PFE - Free Report) Talzenna.
Clovis currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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