Pfizer on Friday announced that the European Commission approved Talzenna (talazoparib) for the treatment of HER2-negative locally advanced or metastatic breast cancer in previously treated adults with germline BRCA1/2 mutations. The oral PARP inhibitor was authorised for the same indication by the FDA last October.
Andreas Penk, Pfizer's regional president for oncology international developed markets, said "today's approval of Talzenna...is the latest example of our successful precision medicine approach to drug development." Penk added "we are thrilled that we can now offer these patients in Europe, who are often diagnosed at a younger age and have limited treatment options, an effective, once-daily alternative...to chemotherapy."
EU approval was backed by data from the Phase III EMBRACA trial, which demonstrated that Talzenna significantly improved progression-free survival (PFS) versus physician's choice standard chemotherapy. The superior PFS benefit with Talzenna was observed across prespecified patient populations, including patients with triple-negative breast cancer, HR-positive/HER2-negative disease, with or without a history of central nervous system metastasis, and those who received prior cytotoxic chemotherapy regimens.
Pfizer gained rights to Talzenna as part of its purchase of Medivation for $14 billion in 2016. BioMarin Pharmaceutical, which prior to that had licenced the treatment out to Medivation, will receive a $15-million milestone payment from Pfizer as a result of the new approval.
Talzenna remains under development for other indications, including early triple-negative breast cancer and prostate cancer. Meanwhile, Pfizer revealed earlier this year that it was terminating Phase III development of the treatment in combination with the anti-PD-L1 therapy Bavencio (avelumab) for use in patients with ovarian cancer in the first-line setting.
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