Earlier this week, the FDA approved Pfizer’s Pfizer’s PARP inhibitor Talzenna (talazoparib) for use in patients with germline BRCA-mutated, HER2‑negative locally advanced or metastatic breast cancer. The agency stated that patients must be selected for therapy based on an FDA-approved companion diagnostic for talazoparib.
Approval was supported by efficacy and safety data from the EMBRACA, an open‑label trial randomizing 431 patients (2:1) with gBRCAm HER2‑negative locally advanced or metastatic breast cancer to receive talazoparib (1 mg) or physician’s choice of chemotherapy (capecitabine, eribulin, gemcitabine, or vinorelbine). The results demonstrated that Talzenna promoted progression-free survival (PFS) according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, as assessed by blinded independent central review.
Pfizer gained rights to Talzenna in 2016 as part of its $14-billion acquisition of Medivation. According to BioMarin Pharmaceutical, which had licensed rights to the therapy to Medivation in a deal valued at as much as $570 million, BioMarin will receive a $15-million milestone payment from Pfizer due to Talzenna’s recent approval.
FDA also approved the BRACAnalysis CDx test (Myriad Genetic Laboratories, Inc.) to identify patients with breast cancer with deleterious or suspected deleterious gBRCAm who are eligible for talazoparib. The effectiveness of the BRACAnalysis CDx test was based on the EMBRACA trial population for whom deleterious or suspected deleterious gBRCAm status was confirmed with either prospective or retrospective testing with BRACAnalysis CDx.
Talzenna is currently under European agency review for the treatment of patients with metastatic breast cancer with an inherited BRCA mutation.
(Sources: The U.S. Food and Drug Administration; Pfizer; Globe Newswire)
