The U.S. FDA has granted approval to Johnson & Johnson’s (NYSE:JNJ) Inlexzo (gemcitabine intravesical system), for certain types of bladder cancer.
While gemcitabine was first approved in 1998 and is currently approved for several different types of cancer, Inlexzo is different as it provides local delivery of the drug directly into the bladder.
Inlexzo stays in the bladder for three weeks per treatment cycle, for up to 14 cycles. It is inserted into the bladder with a urinary catheter and stylet in an outpatient setting in a matter of minutes.
Approval was based on results from the SunRISe-1 single arm, open-label phase 2b study that showed 82% patients with Bacillus Calmette-Guérin-unresponsive, non-muscle invasive bladder cancer given Inlexzo achieved a complete response.
