Johnson & Johnson Receives the US FDA’s Full Approval for Balversa ( erdafitinib) to Treat Locally Advanced or Metastatic Urothelial Carcinoma (UC)
Shots:
- The approval was granted based on the data from the P-III (THOR) clinical trial evaluating Balversa vs SoC CT in patients with metastatic or unresectable UC who received prior treatment with (Cohort 1) or without (Cohort 2) an anti-PD-(L)1. The 1EP of the study includes OS & 2EPs includes PFS, ORR, DOR, safety & PK
- As per the data cutoff on Jan 15, 2023 (median follow-up of 15.9mos.), patients in Cohort 1 depicted an OS of 12.1mos vs 7.8mos, improvement in mPFS of 5.6mos. vs 2.7mos. & an ORR of 45.6% vs 11.5%
- Balversa is an oral FGFR kinase inhibitor indicated for the treatment of locally advanced or mUC that received the US FDA’s accelerated approval in Apr 2019, Priority Review of NDA on Sep 201 & BTD on Mar 2018
Ref: Johnson & Johnson | Image: Johnson & Johnson
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Shivani is a content writer at PharmaShots. She has a keen interest in recent innovations in the life sciences industry. She covers news related to Product approvals, clinical trial results, and updates. She can be contacted at connect@pharmashots.com.
