U.S. FDA Approval of INLEXZO™ (Gemcitabine Intravesical System) Set to Transform How Certain Bladder Cancers Are Treated

U.S. FDA approval of INLEXZO™ (gemcitabine intravesical system) set to transform how certain bladder cancers are treated

First and only drug releasing system to provide extended local delivery of a cancer medication into the bladder, with 82 percent of patients achieving complete response without the need for reinduction1

Behind the FDA approval of Inlexzo in NMIBC, with Sia Daneshmand, MD

Siamak Daneshmand, MD, shares his thoughts on the implications of the Inlexzo approval for clinical practice.

J&J obtains FDA approval for gemcitabine intravesical system

Johnson & Johnson has received approval from the US Food and Drug Administration (FDA) for Inlexzo (gemcitabine intravesical system)The post J&J obtains FDA approval for gemcitabine intravesical system appeared first on Medical Device Network.

Johnson & Johnson wins FDA nod for Inlexzo drug delivery tech

The Inlexzo system. [Image courtesy of Johnson & Johnson]Johnson & Johnson (NYSE:JNJ) announced today that the FDA approved Inlexzo, its gemcitabine intravesical drug delivery system. The intravesical gemcitabine-releasing system, previously known as TAR-200, treats patients with Bacillus Calmette-Guérin (BCG)-unresponsive high-risk non-muscle invasive bladder cancer (HR-NMIBC) with carcinoma in situ (CIS), with or without papillary tumors. A he…

First-Ever Extended Drug Release System: J&J's INLEXZO Achieves 82% Complete Response in Bladder Cancer

FDA approves J&J's INLEXZO, first intravesical drug release system for BCG-unresponsive bladder cancer. 82% complete response rate with 51% maintaining results for 1+ year.