The for patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm), HER2-negative locally advanced or metastatic breast cancer.
The FDA also approved BRACAnalysis CDx from Myriad Genetic Laboratories as the companion diagnostic to identify patients with deleterious or suspected deleterious gBRCAm who are eligible for talazoparib, the agency announced.
Approval was based on improved progression-free survival in EMBRACA, a phase 3, open-label trial of 431 patients with gBRCAm HER2-negative locally advanced or metastatic breast cancer. Patients in the trial were randomized 2:1 to receive either talazoparib (1 mg) or a physician’s choice of chemotherapy (capecitabine, eribulin, gemcitabine, or vinorelbine). All patients had received treatment with an anthracycline and/or a taxane previously.
Median progression-free survival was 8.6 months in the talazoparib arm, compared with 5.6 months in the chemotherapy arm (HR, 0.54; 95% CI, 0.41-0.71; P less than .0001).
Anemia was the most common hematologic adverse event, with grade 3 or greater occurring in 39.2% of patients on the PARP inhibitor, compared with 4.8% of patients treated with other agents, according to results of the trial presented at the 2017 San Antonio Breast Cancer Symposium.
Warnings and precautions for myelodysplastic syndrome/acute myeloid leukemia, myelosuppression, and embryo-fetal toxicity are included in the drug’s prescribing information. The PARP inhibitor’s most common adverse reactions of any grade are fatigue, anemia, nausea, neutropenia, headache, thrombocytopenia, vomiting, alopecia, diarrhea, and decreased appetite, the FDA said.
The recommended dose for talazoparib, marketed as Talzenna by Pfizer, is 1 mg taken as a single oral daily dose, with or without food.