Pfizer Inc. (NYSE: PFE) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending TALZENNA® (talazoparib), 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 2018.1
“There is a pressing need for new, effective medicines that are specifically developed for patients with an inherited BRCA mutation who are often diagnosed at a younger age and have limited options for the treatment of advanced-stage disease,” said Chris Boshoff, M.D., Ph.D., Chief Development Officer, Oncology, Pfizer Global Product Development. “Results from the EMBRACA trial provide evidence supporting the use of TALZENNA in these patients, and we look forward to working with the European Commission to potentially offer an alternative treatment option to chemotherapy.”
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