Shots:
- The CHMP has granted a positive opinion to Balversa monotx. (QD, oral) to treat inoperable mUC adults with susceptible FGFR3 mutations & previously treated with at least 1L of therapy with PD-1/PD-L1 inhibitor
- The opinion was based on the arm 1 of P-III (THOR) trial assessing the safety & efficacy of erdafitinib (n=136) vs CT (n=130) for mUC. Trial was halted, in Jun 2023, at interim analysis with patients randomizing on CT & with an option of crossing over to erdafitinib
- The study showed an mOS of 12.1mos. vs 7.8mos. at the data cut off, improved mPFS of 5.6mos. vs 2.7mos. and ORR of 35.3% vs 8.5%
Ref: Janssen | Image: Janssen | Press Release
Related News:- Roche’s PiaSky Receives the CHMP’s Positive Opinion for Treating Paroxysmal Nocturnal Haemoglobinuria (PNH)
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