Pfizer bid to expand Talzenna label in prostate cancer rejected by FDA

Pfizer (NYSE:PFE) has suffered a setback in its bid to market its antitumor agent Talzenna for a wider group of U.S. patients with prostate cancer after the FDA declined to approve a label expansion for the PARP inhibitor.
Talzenna, already approved for adults with HRR gene-mutated metastatic castration-resistant prostate cancer (mCRPC) with Pfizer’s (NYSE:PFE) Xtandi, has failed to secure an FDA nod for mCRPC patients with non-HRR gene mutations, the company announced late Friday.
The decision comes after an FDA expert panel declined to endorse the company’s supplemental New Drug Application that sought the label change, which would have more than tripled the number of people eligible for the drug.
Given the setback, the New York-based pharma giant said it would no longer seek a label expansion in the U.S. for the Talzenna-Xtandi combo in mCRPC.

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