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| Press Release
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