Astellas received a positive conclusion from CHMP
Astellas Pharma Inc. has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) in the European Union for its marketing authorization application (MAA) of enfortumab vedotin. Enfortumab vedotin has been recommended for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (UC) who have received a platinum-containing chemotherapy and a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor.
Key Points
- Positive opinion from CHMP: Astellas Pharma has received a positive opinion from the CHMP for enfortumab vedotin, a novel antibody-drug conjugate.
- Treatment of advanced urothelial carcinoma: Enfortumab vedotin is recommended for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma that have received platinum-containing chemotherapy and a PD-1 or PD-L1 inhibitor.
- Significant unmet need: Urothelial carcinoma is a type of bladder cancer that affects >500,000 people worldwide each year. There are limited options available for treatment, making enfortumab vedotin an essential addition to therapy.
- Clinical trial results: The CHMP based its decision on positive results from a phase 3 clinical trial where enfortumab vedotin demonstrated significant improvement in overall and progression-free survival rates compared to the standard of care.
- Next steps: The positive opinion from the CHMP is now awaiting approval from the European Commission.
In conclusion, enfortumab vedotin is an essential addition to the treatment options for advanced urothelial carcinoma in patients who have already received platinum-containing chemotherapy and a PD-1 or PD-L1 inhibitor. The positive opinion from the CHMP is a significant milestone for Astellas Pharma and could bring hope to tens of thousands of patients worldwide.