First Targeted Therapy for Metastatic Bladder Cancer Receives FDA Approval – Drug for nerve pain boosts high for opioid abusers. (866) 348-2889
Official with the FDA today granted accelerated approval to erdafitinib (Balversa, Janssen) for adult patients with locally advanced or metastatic bladder cancer. This treatment is used for treating the indicated cancer that has a type of susceptible genetic alteration, FGFR3 or FGFR2, and that has progressed during or following prior platinum-containing chemotherapy.
Erdafitinib was granted a Breakthrough Therapy designation, and it received Accelerated Approval from the FDA. The Accelerated Approval designation enables the agency to focus on drugs for serious conditions that fill an unmet medical need, using clinical trial data that is thought to predict a clinical benefit to patients. Further clinical trials are required to confirm the drug’s clinical benefit.