Balversa
UK's NICE Approves J&J's Balversa for FGFR3-Altered Urothelial Cancer
The recommendation was based on results from the Phase III THOR trial, which compared Balversa to chemotherapy.
J&J's Balversa Approved in Europe for FGFR3-Mutant Bladder Cancer
The approval was based on results from the Phase III THOR study, which compared Balversa to chemotherapy.
FDA Grants Full Approval to Janssen's Balversa in Narrower FGFR-Altered Bladder Cancer Indication
The full approval narrowed the accelerated approval indication to only bladder cancer patients harboring susceptible FGFR3 alterations.
J&J Oncology Revenues Jump 12 Percent in Q3
The firm touted sales gains for Carvykti and highlighted regulatory updates for Akeega, Balversa, and Rybrevant in Q3.
Janssen Seeks Full Approval for Balversa in FGFR3-Altered Bladder Cancer
The firm submitted data from cohort 1 of the Phase III THOR trial, showing Balversa improved survival and response rates versus standard-of-care chemo.