Drugs

J&J’s Bladder Cancer NDA Gets Priority Review

FDA has granted priority review to Johnson & Johnson’s NDA for TAR-200 for treating patients with Bacillus Calmette-Guérin-unresponsive high-risk non-muscle invasive bladder cancer (HR-NMIBC) with carcinoma in situ, with or without papillary tumors. The intravesical drug-releasing system is designed to provide sustained local delivery of gemcitabine into the bladder, J&J says. “It is placed into the bladder by a healthcare professional using a co-packaged urinary placement catheter in an outpatient setting in under five minutes and without the need for anesthesia,” it says.

The priority review decision is based on data from the SunRISe-1 Phase 2b study, which showed a complete response rate of 82.4%, with more than half of those patients (52.9%) remaining cancer-free for at least one year, according to the company. Most side effects were mild to moderate and confined to the urinary tract, including symptoms like frequent urination, discomfort, and urinary tract infections, it adds. No systemic side effects were reported.

FDA previously granted TAR-200 a breakthrough therapy designation and it is being reviewed under the Real-Time Oncology Review program.

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