Johnson & Johnson’s Balversa (Erdafitinib) Receives the EC’s Approval to Treat Urothelial Carcinoma
Shots:
- The EC has approved Balversa (oral, QD) monotx. for treatment-experienced adults with inoperable or metastatic urothelial carcinoma (mUC) having susceptible FGFR3 genetic alterations
- Approval was supported by results of cohort 1 from the P-III (THOR) trial assessing the safety & effectiveness of Balversa (n=136) vs CT (n=130) to treat mUC with select FGFR alterations and has progressed post previous treatments
- In Jun 2023, the THOR study was stopped early due to positive interim results, allowing CT patients to switch to Balversa. Erdafitinib showed mOS of 12.1mos. vs 7.8mos. & mPFS of 5.6mos vs 2.7mos., with a confirmed ORR of 35.3% vs 8.5%
Ref: Johnson & Johnson | Image: Johnson & Johnson
Related News:- Janssen Reports the CHMP’s Positive Opinion of Balversa (Erdafitinib) to Treat Metastatic Urothelial Carcinoma (mUC)
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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.
