
On Tuesday, the U.S. Food and Drug Administration (FDA) approved Johnson & Johnson's (NYSE:JNJ) Inlexzo (gemcitabine intravesical system) as a new treatment approach for certain types of bladder cancer patients who need additional options following unsuccessful BCG therapy and for patients refusing or ineligible for bladder removal surgery (radical cystectomy).
Inlexzo, previously referred to as TAR-200, is indicated for adult patients with Bacillus Calmette-Guérin (BCG)-unresponsive, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumors.