Pfizer Secures EU Approval for TALZENNA in Combination with XTANDI for Metastatic Castration-Resistant Prostate Cancer

EU Approval:
Pfizer's TALZENNA (talazoparib), in combination with XTANDI (enzalutamide), has been approved by the European Commission for the treatment of adults with metastatic castration-resistant prostate cancer (mCRPC), regardless of gene mutations.

Mechanism of Action:
TALZENNA works by blocking PARP enzyme activity and trapping PARP at the site of DNA damage, leading to decreased cancer cell growth and death.

Clinical Trial Results:
The Phase III TALAPRO-2 trial showed that TALZENNA plus XTANDI reduced the risk of disease progression or death by 37% compared to placebo plus XTANDI in patients with mCRPC.

US FDA Approval:
TALZENNA in combination with XTANDI was previously approved by the US FDA for the treatment of adult patients with homologous recombination repair (HRR) gene-mutated mCRPC.

Global Impact:
This approval represents an important advancement for men living with prostate cancer in Europe, offering a new treatment option that addresses disease progression in patients with or without specific gene mutations.