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# Pfizer’s Talzenna OK’d for Breast Cancer
- URL: https://www.fdaweb.com/pfizers-talzenna-okd-for-breast-cancer/
- Published: 2018-10-16T12:00:00.000Z
- Updated: 2026-09-15T00:38:21.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5142595

FDA has approved Pfizer’s Talzenna (talazoparib), a poly (ADP-ribose) polymerase inhibitor for patients with deleterious or suspected deleterious germline BRCA-mutated, HER2‑negative locally advanced or metastatic breast cancer. Patients must be selected for therapy based on results from companion diagnostic BRACAnalysis CDx test (Myriad Genetic Laboratories), an [FDA release](https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm623540.htm?ref=fdaweb.com) says.

Approval was based on data from the EMBRACA open-label trial that randomized 431 patients (2:1) to receive talazoparib (1 mg) or physician’s choice of chemotherapy (capecitabine, eribulin, gemcitabine, or vinorelbine). Estimated median progression-free survival was 8.6 and 5.6 months in the talazoparib and chemotherapy arms, respectively, it says.

  
The prescribing information includes warnings and precautions for myelodysplastic syndrome/acute myeloid leukemia, myelosuppression, and embryo-fetal toxicity. Most common adverse reactions of any grade were fatigue, anemia, nausea, neutropenia, headache, thrombocytopenia, vomiting, alopecia, diarrhea, decreased appetite.