Johnson & Johnson Receives FDA Approval for Gemcitabine for Bladder Cancer Treatment.

Johnson & Johnson has gained FDA approval for Inlexzo (gemcitabine intravesical system), a new treatment for bladder cancer. Gemcitabine was first approved in 1998 and is currently used for various types of cancer. Inlexzo is a local delivery system specifically designed for bladder cancer treatment, making it distinct from other gemcitabine products.

Johnson & Johnson (NYSE: JNJ) has received FDA approval for Inlexzo (gemcitabine intravesical system), a novel treatment for bladder cancer. This approval marks a significant milestone in the company's ongoing efforts to expand its portfolio of innovative cancer therapies.

Inlexzo is a local delivery system designed specifically for bladder cancer treatment, utilizing gemcitabine, an established cancer medication first approved in 1998. Unlike other gemcitabine products, Inlexzo provides extended local delivery of the drug directly into the bladder. This approach is particularly beneficial for patients with certain types of bladder cancer who have not responded to Bacillus Calmette-Guérin (BCG) therapy or are ineligible for bladder removal surgery (radical cystectomy).

The FDA approval is based on the results of the SunRISe-1 (NCT04640623) Phase 2b clinical study, which demonstrated high efficacy and safety for Inlexzo. The study showed that 82% of patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) achieved a complete response (CR) after treatment with Inlexzo. Furthermore, 51% of these patients maintained a complete response for at least one year, indicating strong durability of the treatment.

Inlexzo is administered in an outpatient setting by a healthcare professional using a co-packaged urinary catheter and stylet. The procedure takes only a few minutes and does not require general anesthesia or immediate post-insertion monitoring. This outpatient approach offers patients a convenient and less invasive treatment option compared to traditional methods.

The approval of Inlexzo represents a significant advancement in the treatment of bladder cancer, providing patients with a new option for bladder preservation. It is particularly promising for older patients or those who may be unwilling or unfit to undergo radical cystectomy.

Johnson & Johnson's commitment to innovation and patient care is evident in this approval. The company's dedication to accelerating the development and delivery of important therapies is further underscored by the Breakthrough Therapy Designation (BTD), Real-Time Oncology Review (RTOR), and Priority Review granted by the FDA for Inlexzo.

References:
U.S. FDA approval of INLEXZO™ (gemcitabine intravesical ...^[1] https://www.jnj.com/media-center/press-releases/u-s-fda-approval-of-inlexzo-gemcitabine-intravesical-system-set-to-transform-how-certain-bladder-cancers-are-treated