Janssen Reports the CHMP’s Positive Opinion of Balversa (Erdafitinib) to Treat Metastatic Urothelial Carcinoma (mUC)
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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
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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
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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: Johnson & Johnson | Image: Johnson & Johnson
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A passionate content writer with expertise in delivering high-quality and engaging content, Dipanshu is a keen reader and a versatile writer. Dipanshu dedicatedly covers news ranging from biopharma, life sciences, biotech, and MedTech to diagnostics and animal health companies, FDA, EMA, and biosimilar approvals. He can be contacted at connect@pharmashots.com
