Talazoparib to treat gBRCAm breast cancerDecember 13, 2018
Talazoparib (Talzenna) has been cleared by US FDA for patients with deleterious germline BRCA-mutated (gBRCAm), HER2-negative metastatic breast cancer.
Developed by Pfizer, talazoparib is a poly (ADP-ribose) polymerase (PARP) inhibitor.
The approval was based on 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 primary efficacy outcome was progression-free survival (PFS), according to Response Evaluation Criteria in Solid Tumours (RECIST) 1.1, as assessed by a blinded independent central review. Estimated median PFS was
8.6 months and 5.6 months in the talazoparib and chemotherapy arms, respectively (HR 0.54; 95% CI: 0.41, 0.71; p<0.0001).
Patients must be selected for therapy based on an FDA-approved companion diagnostic for talazoparib, Pfizer said.
FDA also approved the BRACAnalysis CDx test developed by Myriad Genetic Laboratories, Inc to identify patients with breast cancer with deleterious or suspected deleterious gBRCAm who are eligible for talazoparib.