Datapoint: J&J Receives Full Approval for Balversa
The FDA on Jan. 19 granted Johnson & Johnson’s Balversa (erdafitinib) full approval for the treatment of locally advanced or metastatic urothelial carcinoma in patients with susceptible FGFR3 genetic alterations who have already received at least one other line of therapy. The FGFR kinase inhibitor was received accelerated approval in 2019 for use in patients with susceptible mutations on the FGFR3 or FGFR2 genes after platinum-based chemotherapy. Notably, patients that have not received a prior PD-1/L1 therapy are ineligible to use Balversa. For the treatment of bladder cancer, the once-daily pill holds covered or betters status for 95% of all insured lives. Just 17% have preferred access, largely with utilization management restrictions applied.
SOURCE: MMIT Analytics, as of 1/29/24
