With this FDA action, Talzenna (talazoparib) is the second PARP inhibitor to be approved in the breast cancer space.
The Food and Drug Administration (FDA) approved Talzenna (talazoparib) to treat patients with deleterious or suspected deleterious germline BRCA-mutant, HER2-negative locally advanced or metastatic breast cancer.
The FDA also noted that patient selection for treatment with the agent must be based on an FDA-approved companion diagnostic, BRACAnalysis CDx test, which was also granted approval.
The agency based its approvals on data from the open-label, phase 3 EMBRACA trial — designed to evaluate Talzenna compared with chemotherapy in 431 patients with HER2-negative, germline BRCA-mutant locally advanced or metastatic breast cancer.
Participants could have no more than three prior cytotoxic chemotherapy regimens for locally advanced or metastatic disease, and they were required to have received treatment with an anthracycline and/or taxane (unless they were not eligible for that treatment) in the neoadjuvant (before treatment), adjuvant (during treatment) and/or metastatic setting.
Patients were randomized to receive 1 mg of Talzenna or physician’s choice of chemotherapy — capecitabine, eribulin, gemcitabine or vinorelbine.
Estimated average progression-free survival (time to disease progression or death) in the Talzenna arm was 8.6 months compared to 5.6 months in the chemotherapy arm.
In a recent interview with CURE, Jennifer Litton, M.D., associate professor of breast medical oncology at The University of Texas MD Anderson Cancer Center, noted that patients also had improved quality of life while taking Talzenna.
“PARP inhibitors were directly compared to several standard chemotherapy regimens and were found to be better as far as disease control; but just as importantly, patients felt better when compared with chemotherapy,” she said in August 2018, while explaining the EMBRACA trial.
Talzenna is the second PARP inhibitor to be approved for the treatment of breast cancer — Lynparza (olaparib) being the first.
The prescribing information includes warnings and precautions for myelodysplastic syndrome/acute myeloid leukemia, myelosuppression, and embryo-fetal toxicity. Most common side effects of any grade that occurred in at least 20 percent of patients were fatigue, anemia, nausea, neutropenia, headache, thrombocytopenia, vomiting, alopecia, diarrhea and decreased appetite.
“We congratulate Pfizer on obtaining FDA approval of TALZENNA for certain patients living with metastatic breast cancer, and we are excited to expand the use of BRACAnalysis CDx as the companion diagnostic test,” said Lloyd Sanders, president, Myriad Oncology, in a statment. “We estimate there are more than 60,000 patients diagnosed with or who progress to metastatic breast cancer in the United States every year who qualify for a BRACAnalysis CDx test.”