Drugs

J&J Bladder Cancer Drug Under Review

FDA has accepted for review a Johnson & Johnson NDA for TAR-200 (gemcitabine), an intravesical drug-releasing system 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 company says the submission is being reviewed under the agency’s Real-Time Oncology Review program, which allows data to be reviewed before the complete application is formally submitted.

The submission is based on data from the Phase 2b SunRISe-1 registration study that “showed an 83.5% complete response (CR) rate and highly durable CRs without the need for reinduction,” J&J says. The data also demonstrated a low occurrence of Grade 3 or higher treatment-related adverse events (9%); five patients had adverse events leading to discontinuation (6%) and no treatment-related deaths were reported, it adds.

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.

J&J says that HR-NMIBC is more likely to recur or spread beyond the lining of the bladder (urothelium) and progress to invasive bladder cancer compared to low-risk NMIBC.

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