Pfizer Inc. has announced a significant development in the treatment of metastatic castration-resistant prostate cancer (mCRPC) with the European Commission’s approval of TALZENNA® (talazoparib) in combination with XTANDI® (enzalutamide). This marks the first approval of a poly ADP-ribose polymerase (PARP) inhibitor, TALZENNA, combined with the standard of care, XTANDI, for mCRPC patients in the European Union, offering a new ray of hope for patients battling this advanced stage of prostate cancer.
Key Highlights of TALZENNA® and XTANDI® Combination Approval
- Novel Treatment for mCRPC: TALZENNA, an oral PARP inhibitor, in combination with XTANDI, has been approved for the treatment of adult patients with mCRPC where chemotherapy is not clinically indicated. This combination therapy is now the first and only PARP inhibitor licensed in the EU for use with XTANDI for mCRPC patients, with or without gene mutations.
- Significance of the Approval: According to Professor Robert Jones, MBChB, PhD, of the University of Glasgow, this approval represents a meaningful advancement for treating patients with mCRPC. Erik Briers, MS, PhD, Vice Chairman of Europa UOMO, highlighted the urgent need for new treatment options at this advanced and aggressive disease stage, and how this combination therapy can bring new hope to patients.
- Geographical Scope of Approval: The approval by the European Commission is valid in all 27 EU member states, as well as Iceland, Liechtenstein, and Norway, broadening the availability of this treatment across Europe.
- Basis of Approval – Phase 3 TALAPRO-2 Trial: The approval is grounded on data from the Phase 3 TALAPRO-2 trial, a randomized, double-blind, placebo-controlled study. The trial evaluated two mCRPC patient cohorts: all-comers (n=805) and those with homologous recombination repair (HRR) gene mutations (HRRm; n=399).
- Primary Endpoint Results: The results, published in The Lancet, demonstrated that TALZENNA plus XTANDI reduced the risk of disease progression or death by 37% compared to placebo plus XTANDI. The median radiographic progression-free survival (rPFS) for patients treated with the combination had not been reached, compared to 21.9 months for the placebo group.
- Safety Profile: The safety of TALZENNA plus XTANDI in the TALAPRO-2 trial was consistent with the known safety profiles of each medicine.
- Implications for Treatment: Chris Boshoff, M.D., Ph.D., Chief Oncology Officer at Pfizer, emphasized that this approval represents a significant advancement for men living with prostate cancer in Europe. The trial’s results indicated that the combination offers an effective treatment that addresses disease progression in patients with or without specific gene mutations.
- Global Regulatory Progress: Following its approval by the U.S. Food and Drug Administration (FDA) in June 2023 for HRR gene-mutated mCRPC, Pfizer has shared the TALAPRO-2 data with other regulatory agencies to support additional regulatory filings.
A Significant Breakthrough in Prostate Cancer Treatment
In conclusion, the approval of TALZENNA in combination with XTANDI marks a milestone in the treatment landscape of mCRPC, providing a new therapeutic option for patients, particularly those for whom chemotherapy is not a viable option. This combination therapy not only addresses the disease progression but also expands the treatment possibilities for patients with varying genetic backgrounds of prostate cancer. The European Commission’s approval underscores the potential of this combination therapy in improving the outcomes and quality of life for patients suffering from one of the most challenging forms of prostate cancer.
Resource: Pfizer, January 09, 2024
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