The FDA on Tuesday for the treatment of locally advanced or metastatic breast cancer patients with a germline BRCA mutation.
Based on results of the EMBRACA trial, talazoparib -- a poly-ADP ribose polymerase (PARP) inhibitor -- is indicated for patients who have received no more than three prior cytotoxic chemotherapy regimens, including an anthracycline and a taxane (if not contraindicated) either in the neoadjuvant, adjuvant, or metastatic setting.
EMBRACA randomized 431 patients 2:1 to treatment with single-agent talazoparib at 1 mg or standard chemotherapy with either capecitabine, eribulin, gemcitabine, or vinorelbine -- depending on investigator's choice. In these locally advanced or metastatic HER2-negative patients with a deleterious or suspected deleterious germline BRCA mutation, the drug showed improvement in the study's primary endpoint of progression-free survival: 8.6 months with talazoparib versus 5.6 months with chemotherapy (HR 0.54, 95% CI 0.41-0.71, P<0.0001).
The overall response rate was also significantly higher in the talazoparib arm (62.6% versus 27.2%, OR 5.0, 95% CI 2.9-8.8 P<0.001).
Results of the the study were first presented last year at the San Antonio Breast Cancer Symposium and recently published in the .
The drug is to be used with a companion diagnostic to identify patients with breast cancer with these germline BRCA mutations.
"Myriad's BRACAnalysis CDx test was shown in the EMBRACA trial to accurately identify certain patients with a germline BRCA-mutation who may benefit from Talzenna," Johnathan Lancaster, MD, PhD, the company's chief medical officer, said in a .
The drug is the second PARP inhibitor for breast cancer approved this year, following the approval of olaparib (Lynparza) in January, which was also approved for use with the same diagnostic.
Warnings for talazoparib include increased risk of myelosuppression and embryo-fetal toxicity, as well as higher risk of secondary malignancies (myelodysplastic syndrome and acute myeloid leukemia). Alopecia, anemia, fatigue, headache, nausea and vomiting, neutropenia, thrombocytopenia, diarrhea, and decreased appetite were among the most common adverse events (≥20%).