FDA approves Talzenna for mCRPC

21 June 2023

The US Food and Drug Administration (FDA) yesterday approved US pharma giant Pfizer’s (NYSE: PFE) Talzenna (talazoparib) in combination with Xtandi (enzalutamide) for homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC). This application was granted priority review.

Around 10%-20% of patients with prostate cancer develop mCRPC within five-seven years of diagnosis, and in the USA in 2020, about 60-90 thousand of the three million cases of prostate cancer were mCRPC.

Talzenna is already approved in over 70 countries, including the USA, as a once-daily monotherapy for the treatment of adult patients with deleterious or suspected deleterious germline breast cancer susceptibility gene (BRCA)-mutated (gBRCAm) human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer.

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