FDAnews Drug Daily Bulletin
Pharmaceuticals / Submissions and Approvals

Pfizer Gets FDA Nod for Breast Cancer Drug

Oct. 24, 2018
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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.

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