The European Commission approved Pfizer Inc.'s (PFE) Talzenna or talazoparib, an oral poly ADP-ribose polymerase (PARP) inhibitor, in combination with Xtandi or enzalutamide, for the treatment of adult patients with metastatic castration-resistant prostate cancer or mCRPC in whom chemotherapy is not clinically indicated, the company said in a statement.
With this approval, Talzenna is now the first and only PARP inhibitor licensed in the European Union for use with Xtandi for patients with mCRPC, with or without gene mutations.
The approval by the European Commission of Talzenna in combination with Xtandi for the mCRPC indication is valid in all 27 EU member states plus Iceland, Liechtenstein, and Norway.
Talzenna in combination with Xtandi was approved by the U.S. Food and Drug Administration for the treatment of adult patients with HRR gene-mutated mCRPC in June 2023. Pfizer has also shared the TALAPRO-2 data with other regulatory agencies to support regulatory filings.
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