FDAnews Drug Daily Bulletin
Pharmaceuticals / Submissions and Approvals

Pfizer Gets FDA Nod for Breast Cancer Drug

Oct. 24, 2018

The FDA approved Pfizer’s Talzenna (talazoparib) for treatment of certain forms of breast cancer.

The drug is indicated for treatment of patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm), HER2-negative locally advanced or metastatic breast cancer. Patients must be selected based on an FDA-approved companion diagnostic.

The agency based its approval on the results of a 431-patient trial. The most common adverse reactions to the drug included fatigue, anemia, headache, decreased appetite and hair loss.

View today's stories