▎WuXiEdited by Kant Content Team

Johnson & Johnson today announced that the European Commission (EC) has approved its small molecule inhibitor Balversa (erdafitinib) as a once-daily oral monotherapy for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (mUC) who have fibroblast growth factor receptor 3 (FGFR3) gene mutations and have previously received at least one line of treatment with a PD-1/PD-L1 inhibitor. According to the press release,This is the EU approval for the treatment ofFGFR3Adult patients with variant mUCThe first pan-FGFR kinase inhibitor。

This approval is mainly 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 than those treated with 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.

Balversa is a once-daily oral FGFR kinase inhibitor.Approximately 20% of mUC patients carryFGFRGene mutation, Balversa achieves its therapeutic effect by inhibiting FGFR. This therapy received the FDA's Breakthrough Therapy Designation (BTD) in 2018 and was granted accelerated approval by the FDA in April 2019.

References:

[1] European Commission approves BALVERSA®▼ (erdafitinib) for adult patients with unresectable or metastatic urothelial carcinoma. Retrieved August 23, 2024 from https://www.globenewswire.com/news-release/2024/08/23/2934847/0/en/European-Commission-approves-BALVERSA-erdafitinib-for-adult-patients-with-unresectable-or-metastatic-urothelial-carcinoma.html

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