The FDA on Tuesday announced the approval of Pfizer's PARP inhibitor Talzenna (talazoparib) for use in patients with germline BRCA-mutated, HER2‑negative locally advanced or metastatic breast cancer. The agency also authorised Myriad Genetic Laboratories' companion diagnostic BRACAnalysis CDx test for identifying patients eligible to receive the treatment.
The FDA said approval of the drug was supported by efficacy and safety data from the EMBRACA trial, in which 431 patients with germline BRCA-mutated, HER2‑negative locally advanced or metastatic breast cancer were assigned to receive treatment with talazoparib or physician's choice of chemotherapy, consisting of capecitabine, eribulin, gemcitabine or vinorelbine. Results from the study, which were unveiled in December last year, have shown that Talzenna prolonged progression-free survival versus chemotherapy.
Pfizer gained rights to Talzenna as part of its $14-billion acquisition of Medivation in 2016. BioMarin Pharmaceutical, which had licenced rights to the therapy to Medivation in a deal valued at as much as $570 million, said that based on the therapy's approval, it will receive a $15-million milestone payment from Pfizer.
Meanwhile, Talzenna also remains under review in Europe for the treatment of patients with metastatic breast cancer with an inherited BRCA mutation.
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