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- Johnson & Johnson (NYSE:JNJ) on Friday received full FDA approval for its bladder cancer therapy erdafitinib (Balversa) as a late-line option for certain patients with urothelial carcinoma.
- Accordingly, the once-daily oral FGFR kinase inhibitor will be indicated in the U.S. after systemic therapy for adults with urothelial carcinoma harboring FGFR3 alterations, as proven by an FDA-approved test.
- In 2019, the FDA granted accelerated approval for erdafitinib as a treatment for adults with locally advanced or metastatic urothelial carcinoma with FGFR3 or FGFR2 genetic alterations after at least one line of platinum-containing chemotherapy.
- In August, JNJ’s Janssen unit submitted a supplemental new drug application ((sNDA)) seeking its full approval based on data from its Phase 3 THOR trial, which had met the primary endpoint of overall survival.
