▎WuXiEdited by Kant Content Team

Recently, Johnson & Johnson announced that its small molecule inhibitor Balversa (erdafitinib) has received full approval from the U.S. FDA for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (mUC) who haveFGFR3Genetic variation and disease progression after at least one line of systemic treatment.According to the press release, Balversa is the first approved oral fibroblast growth factor receptor (FGFR) kinase inhibitor and is used for treating patients withFGFRThe first targeted drug for patients with mutant mUC.

This approval decision is based on the positive results of the Phase 3 clinical trial (THOR). The trial is a randomized, open-label, multicenter study enrolling mUC patients with specificFGFRGenetic mutations, and disease progression occurred during or after receiving first-line or second-line treatment. The THOR trial results showed that when used for second-line treatment, compared with chemotherapy, in patients who had previously received PD-1 or PD-L1 inhibitor treatment,Balversa Improves Overall Survival and Reduces Risk of Death by 36%. Median survival was 4 months longer in patients treated with Balversa compared to those receiving chemotherapy (HR: 0.64; 95% CI: 0.47–0.88; P=0.0050).

Common adverse reactions related to Balversa include elevated phosphate levels, nail disorders, stomatitis, diarrhea, etc.

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References:

[1] U.S. Food and Drug Administration Grants Full Approval for BALVERSA® to Treat Locally Advanced or Metastatic Bladder Cancer with Select Genetic Alterations. Retrieved January 19, 2024 from https://www.jnj.com/u-s-food-and-drug-administration-grants-full-approval-for-balversa-to-treat-locally-advanced-or-metastatic-bladder-cancer-with-select-genetic-alterations

[2] HOW BALVERSA® WORKS Retrieved January 19, 2024 from https://www.balversa.com/about-balversa/how-balversa-works

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