J&J's Balversa gets accelerated approval for bladder cancer

FDA granted Janssen's Balversa erdafitinib accelerated approval to treat bladder cancer, making it the first FGFR kinase inhibitor to gain U.S. approval.

Balversa is indicated to treat adults with locally advanced or metastatic urothelial carcinoma with susceptible FGFR3 or FGFR2 alterations and who have progressed during or following at least one line of platinum-containing chemotherapy. FDA simultaneously approved the therascreen FGFR RGQ RT-PCR Kit from Qiagen N.V. (Xetra:QIA; NYSE:QGEN) for use as a companion diagnostic with Balversa...