Drugs

FDA Approves J&J’s New Bladder Cancer Therapy

FDA has approved a Johnson & Johnson NDA for Inlexzo (gemcitabine intravesical system), offering a new treatment option for adults with non-muscle invasive bladder cancer (NMIBC) who do not respond to standard Bacillus Calmette-Guérin (BCG) therapy. The therapy is the first intravesical drug-releasing system designed to deliver continuous local release of chemotherapy directly into the bladder, according to the company. It is indicated for patients with BCG-unresponsive NMIBC with carcinoma in situ, with or without papillary tumors, and may provide a bladder-sparing alternative to radical cystectomy. Inlexzo is designed to be inserted in the bladder for three weeks per treatment cycle and can be used for up to 14 cycles, it says.

Approval was based on data from the Phase 2b SunRISe-1 trial, which found that 82% of patients achieved a complete response, with more than half maintaining that response for at least a year. The most common adverse events included urinary tract infections, bladder irritation, and changes in lab values such as decreased hemoglobin and increased creatinine.

Bladder cancer is among the most common cancers in the U.S., with NMIBC making up the majority of cases, according to the company. Patients who fail BCG treatment are often advised to undergo radical cystectomy, a surgery associated with significant risks and quality-of-life impacts, it says.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome