Talazoparib is filed in Japan for treatment of BRCA-mutated, HER2-negative, inoperable or recurrent breast cancer
Pfizer Japan has filed a new drug application in Japan for its PARP inhibitor talazoparib for the treatment of “BRCA-mutated, HER2-negative, inoperable or recurrent breast cancer” and “castration-resistant prostate cancer (CRPC).”
For breast cancer, the submission is based on the results of an overseas PIII trial called EMBRACA and a domestic PI study, both in patients who have locally advanced or metastatic breast cancer with BRCA mutations. In the EMBRACA trial, patients who received talazoparib showed significantly longer progression-free survival (PFS), the primary endpoint, than those given a physician’s choice standard of care chemotherapy.
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