CHMP recommends approval of Talzenna in HER2- breast cancer

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending Talzenna (talazoparib), from Pfizer, an oral poly (ADP-ribose) polymerase (PARP) inhibitor, be granted marketing authorization in the European Union (EU). The indication the CHMP adopted is for Talzenna as monotherapy for the treatment of adult patients with germline breast cancer susceptibility gene (gBRCA)1/2-mutations, who have human epidermal growth factor receptor 2-negative (HER2-) locally advanced (LA) or metastatic breast cancer (MBC).

Patients should have been previously treated with an anthracycline and/or a taxane in the (neo)adjuvant, locally advanced or metastatic setting unless patients were not suitable for these treatments. Patients with hormone receptor-positive (HR+) breast cancer should have been treated with a prior endocrine-based therapy, or be considered unsuitable for endocrine-based therapy. The positive CHMP opinion of Talzenna follows the medicine’s approval by the U.S. Food and Drug Administration (FDA) in October 2018.

The Marketing Authorization Application was submitted based on results from the EMBRACA trial, the largest Phase III trial performed to date of a PARP inhibitor in patients with gBRCA-mutated LA or MBC. This Phase III, open-label, randomized trial evaluated once-daily Talzenna compared to physician’s choice standard chemotherapy (capecitabine, eribulin, gemcitabine or vinorelbine) in patients with an inherited BRCA1/2 mutation and triple-negative or HR+/HER2- LA or MBC who may have received up to three prior cytotoxic chemotherapy regimens for their advanced disease. A total of 431 patients were enrolled at 145 sites in 16 countries, including 190 patients in European countries such as Belgium, France, Germany, Ireland, Italy, Poland, Spain and the United Kingdom.