Johnson & Johnson's FDA-Approved Bladder Cancer Drug Offers New Option For Patients Avoiding Surgery

On Tuesday, the U.S. Food and Drug Administration (FDA) approved Johnson & Johnson's 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.

Inlexzo is designed for patients seeking bladder preservation and is the first and only intravesical drug-releasing system (iDRS) to provide extended local delivery of a cancer medication into the bladder.

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Inlexzo remains in the bladder for three weeks per treatment cycle for up to 14 cycles.

A healthcare professional inserts Inlexzo into the bladder using a co-packaged urinary catheter and stylet.

Inlexzo is placed in an outpatient setting in a few minutes, without the need for general anesthesia or further monitoring immediately post-insertion within the healthcare provider's office.

The approval is supported by data from the SunRISe-1 Phase 2b study.

Results show 82% of patients with BCG-unresponsive NMIBC treated with Inlexzo achieved a complete response (CR), meaning no signs of cancer were found after treatment.

This high response rate demonstrated strong durability, and 51% of these patients maintained a complete response for at least one year.

Goldman Sachs, an investor, said the approval could launch "a powerful new product cycle" for the company's TAR-200 program.

The analyst stated that the company expects Inlexzo to be covered by Medicare and most commercial insurance plans, which could drive strong market adoption.

Price Action: JNJ stock is down 0.64% at $175.82 at the last check Wednesday.

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