EU and US to review Pfizer’s talazoparib

The EU and the US will review Pfizer’s PARP inhibitor talazoparib as a treatment for women with a hereditary BRCA mutation. The US are considering it as a priority, which will hopefully reduce the regulatory assessment timeframe.
The EMBRACA trial compared talazoparib with chemotherapy in patients with germline (inherited) BRCA-mutated (gBRCAm), HER2-negative locally advanced or metastatic breast cancer. Patients treated with talazoparib had an 8.6 months progression-free survival (PFS) and were 45.8% less likely to have disease progression. Patients treated with chemotherapy only had a 5.6 month PFS. This was also the case in predetermined subgroups, including those previously treated with chemotherapy and those with a history of brain metastases.
Mace Rothenberg, chief development officer, Oncology, Pfizer Global Product Development, said : “The filing acceptances in the US and EU are an example of the success of Pfizer’s precision medicine approach to drug development, in this case targeting the faulty DNA damage repair process linked with BRCA mutations.”