FDA Approves Johnson & Johnson's INLEXZO For BCG-Unresponsive Bladder Cancer

(RTTNews) - Johnson & Johnson (JNJ) announced that the U.S. Food and Drug Administration has approved INLEXZO (gemcitabine intravesical system), a novel and potentially practice-changing treatment for certain types of bladder cancer. INLEXZO addresses the need for additional options following unsuccessful Bacillus Calmette-Guérin (BCG) therapy and for patients who are either ineligible for or refuse bladder removal surgery (radical cystectomy). Previously known as TAR-200, INLEXZO is indicated for adult patients with BCG-unresponsive, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumors.

INLEXZO is the first and only drug-releasing system designed to deliver extended local therapy directly into the bladder for cancer treatment. This innovative approach has demonstrated remarkable efficacy, with 82 percent of patients achieving a complete response—without requiring reinduction therapy, the company said.

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