Talzenna (talazoparib)

The approval of Talzenna (talazoparib) was based on the results of EMBRACA, an open‑label clinical study randomizing 431 patients (2:1) with gBRCAm HER2‑negative locally advanced or metastatic breast cancer to receive Talzenna (talazoparib) (1 mg) or physician’s choice of chemotherapy (capecitabine, eribulin, gemcitabine, or vinorelbine). All patients were required to have a known deleterious or suspected deleterious gBRCA mutation and must have received no more than 3 prior cytotoxic chemotherapy regimens for locally advanced or metastatic disease. Patients were required to have received treatment with an anthracycline and/or a taxane (unless contraindicated) in the neoadjuvant, adjuvant, and/or metastatic treatment setting. The primary efficacy outcome was progression-free survival (PFS). Estimated median PFS was 8.6 and 5.6 months in the talazoparib and chemotherapy arms, respectively. ¹

Talzenna (talazoparib) can cause fetal harm when administered to a pregnant woman. Females of reproductive potential are advised to use effective contraception during treatment and for at least 7 months following the last dose of Talzenna (talazoparib). Male patients with female partners of reproductive potential or who are pregnant are advised to use effective contraception during treatment and for at least 4 months after receiving the last dose of Talzenna (talazoparib). ²

Please refer to the full prescribing information below for comprehensive information about the safety and effectiveness of Talzenna (talazoparib) for the approved indication. ²

References

1. U.S. Food and Drug Administration. FDA approves talazoparib for gBRCAm HER2-negative locally advanced or metastatic breast cancer. 16/10/2018 (last update: 14/12/2018), cited on 03/01/2020.

2. Full prescribing information [FDA]: Talzenna (talazoparib) [PDF], Pfizer, Inc., Oct.2018.