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FDA Approves Drug and Companion Test for Specific Breast Cancer Type
The FDA granted approval to talazoparib (Talzenna; Pfizer) for use in the treatment of patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) HER2-negative, locally advanced or metastatic breast cancer.
Approval was also granted to the companion diagnostic test, BRACAnalysis CDx (Myriad Genetic Laboratories), which is used to identify patients eligible to receive talazoparib.
Talazoparib, a PARP inhibitor, was approved based on the EMBRACA clinical trial, which enrolled 431 patients with gBRCAm, HER2-negative, locally advanced or metastatic breast cancer. The patients were randomized in a 2:1 ratio to receive talazoparib) or physician’s choice of chemotherapy. The primary end point was progression-free survival (PFS).
The estimated median PFS rates were 8.6 months and 5.6 months in the talazoparib and chemotherapy arms, respectively.
The most common (20% or greater) adverse reactions of any grade seen with talazoparib were fatigue, anemia, nausea, neutropenia, headache, thrombocytopenia, vomiting, alopecia, diarrhea, decreased appetite.
The approval of BRACAnalysis CDx was also based on the EMBRACA trial, in which deleterious or suspected deleterious gBRCAm status of patients was confirmed with prospective or retrospective testing using the diagnostic.—Janelle Bradley
