European Medicines Agency Recommends Approval of Four Cancer Drugs

The European Medicines Agency (EMA) recently issued positive opinions for four novel cancer therapies, signifying a major advancement in the fight against various malignancies. These approvals offer promising treatment options for patients with urothelial carcinoma, lymphomas, prostate cancer, and chronic myelogenous leukemia (CML).

Targeted Therapy for Advanced Urothelial Carcinoma

• Balversa (erdafitinib), developed by Janssen-Cilag International N.V., is a targeted therapy specifically designed for adult patients with advanced urothelial carcinoma harboring specific FGFR3 genetic mutations. Urothelial carcinoma is the most common form of bladder cancer, and this targeted approach offers hope for patients whose cancer has progressed after receiving prior treatment with immune checkpoint inhibitors (PD-1/PD-L1 inhibitors).
• Clinical trials evaluating Balversa were particularly encouraging. The therapy demonstrated a significant improvement in overall survival and progression-free survival compared to standard chemotherapy in this patient population. Additionally, it yielded a considerably higher objective response rate, signifying a greater chance of tumors shrinking in response to treatment.

Immunotherapy for Relapsed or Refractory Lymphomas

• Ordspono (odronextamab), from Regeneron Ireland Designated Activity Company, ushers in a new era of immunotherapy for adult patients with relapsed or refractory follicular lymphoma (FL) and diffuse large B-cell lymphoma (DLBCL). Ordspono is a bispecific antibody therapy, a unique approach that harnesses the power of the immune system to fight cancer. It works by simultaneously targeting two specific cell types: CD20-expressing B cells, the malignant cells in these lymphomas, and CD3-expressing T cells, immune system cells crucial for attacking cancer cells. By essentially bringing these two cell types together, Ordspono stimulates a targeted immune response against the lymphoma cells.
• Phase 2 clinical trials have shown promising results with Ordspono, demonstrating high overall response rates and a significant number of patients achieving complete remission in both FL and DLBCL cohorts. These results suggest that Ordspono has the potential to become a valuable treatment option for patients with these aggressive lymphomas who have exhausted other treatment options.

Expanding Access to Established Therapies Through Generics

• The EMA’s recommendations also encompass two generic versions of existing cancer medications, providing broader access to established therapies and potentially reducing treatment costs.
  • Enzalutamide Viatris (enzalutamide) is a bioequivalent generic of Xtandi, indicated for the treatment of various stages of prostate cancer in men. This approval offers a more cost-effective treatment option while maintaining the same efficacy profile as the originator drug.
  • Nilotinib Accord (nilotinib) is a generic form of Tasigna, approved for treating the chronic and accelerated phases of CML in both adult and pediatric patients. This generic version broadens access to this well-established therapy for CML management, potentially reducing treatment costs and improving affordability for patients.

In conclusion, the EMA’s recent approvals represent a significant step forward in the European oncological armamentarium. These new treatment options offer enhanced efficacy for specific cancers, introduce a novel immunotherapy approach for lymphomas, and expand access to established therapies through generic medications. These advancements hold great promise for improving the lives of cancer patients in Europe.