Chris Boshoff, MD, PhD
The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has backed approval of talazoparib (Talzenna) for adult patients with HER2-negative locally advanced or metastatic breast cancer harboring germline BRCA1/2
mutations, according to Pfizer, the manufacturer of the PARP inhibitor.
If approved, the indication would stipulate that eligible patients must have prior treatment with an anthracycline and/or a taxane in the neoadjuvant/adjuvant locally advanced or metastatic setting. Further, eligible patients with HR-positive disease must first have received endocrine-based therapy. The European Commission will now be reviewing the application for a final approval decision.
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