Dive Brief:
- In a decision reached two months earlier than expected, U.S. regulators approved Pfizer's PARP inhibitor Talzenna for a certain type of breast cancer.
- The OK, announced by the FDA on Tuesday, clears Talzenna as a treatment for patients with deleterious or suspected deleterious germline BRCA-mutated HER2-negative locally advanced or metastatic breast cancer. Patients must be diagnosed using a companion diagnostic, which the agency approved alongside Talzenna.
- Pfizer supported Talzenna's application with results from a Phase 3 study dubbed EMBRACA, which showed that Talzenna extended median progression-free survival by about three months versus standard-of-care chemotherapy.
Dive Insight:
Pfizer's PARP inhibitor Talzenna (talazoparib) will hit the market earlier than anticipated after FDA's decision. Talzenna was given Priority Review status in June, with a Prescription Drug User Fee Act decision date of December.
Pfizer acquired Talzenna in 2016 through its $14 billion deal for Medivation, in which it outbid Sanofi. While the deal's central focus was Medivation's partial rights to the prostate cancer drug Xtandi (enzalutamide), Talzenna was a key pipeline asset and factored into Medivation's valuation.
As a PARP inhibitor, Talzenna will join a crowded drug class. AstraZeneca's Lynparza (alaparib) was the first PARP inhibitor to market, and is approved for maintenance treatment of recurrent ovarian cancer, for advanced ovarian cancer in patients with a BRCA mutation, and for metastatic breast cancer in patients with a BRCA mutation.
Clovis Oncology's Rubraca (rucaparib) and Tesaro's Zejula (niraparib), meanwhile, are only approved for ovarian cancer indications.
Talzenna is also being assessed in a Phase 3 trial for untreated advanced ovarian cancer in combination with Bavencio (avelumab), developed by Merck KGaA and Pfizer.
Approval of Talzenna adds another approved asset to Pfizer's growing cancer portfolio. Last month, the FDA granted an OK to the pharma's Vizimpro (dacomitinib) for a certain type of lung cancer.