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FDA grants priority review to talazoparib for breast cancer subtype
The FDA granted priority review designation to talazoparib for the treatment of patients with germline BRCA-mutated HER-2-negative locally advanced or metastatic breast cancer, according to a manufacturer-issued press release.
Talazoparib (Pfizer) is an oral poly ADP ribose polymerase inhibitor that is not yet approved for any indication.
“Women with a hereditary BRCA mutation are typically diagnosed with breast cancer at a younger age than the overall breast cancer population and have limited treatment options when they develop advanced disease,” Mace Rothenberg, MD, chief development officer of oncology at Pfizer, said in a press release.
The FDA based the priority review designation on results from the EMBRACA trial evaluating once-daily talazoparib compared with physician’s choice of chemotherapy. The analysis included 431 patients with germline BRCA1/BRCA2 mutation and locally advanced or metastatic triple-negative breast cancer or hormone receptor-positive, HER-2-negative breast cancer.
The trial met its primary endpoint of improved PFS among patients treated with talazoparib compared with chemotherapy. Researchers observed prolonged PFS across prespecified subgroups, including those with a history of brain metastases and those previously treated with chemotherapy.
The most common grade 3 or higher adverse events with talazoparib included anemia (35%), neutropenia (17%) and thrombocytopenia (17%).