FDA nod for Janssen’s Inlexzo in NMIBC

The US Food and Drug Administration has approved Janssen Biotech’s Inlexzo (gemcitabine) intravesical system for adults with Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors.

Gemcitabine intravesical system – previously dubbed TAR-200 - is co-packaged with a urinary catheter and stylet used for insertion through the urinary catheter into the bladder, said Janssen, a part of US healthcare giant Johnson & Johnson (NYSE: JNJ). J&J acquired rights to the product along with its buy of TARIS Biomedical in 2019.