FDA Policy/General

J&J Reports Favorable TAR-200 Clinical Data

Johnson & Johnson reports that data from Cohort 2 of the Phase 2b SunRISe-1 study evaluating investigational TAR-200 monotherapy in patients with Bacillus Calmette-Guérin (BCG)-unresponsive high-risk, non–muscle-invasive bladder cancer (HR-NMIBC) with carcinoma in situ showed a high complete response rate and durability of response. The study is evaluating the therapy in patients who are ineligible for, or decline, radical cystectomy.

The results of 85 patients who received TAR-200 monotherapy showed a complete response rate of 82.8% by urine cytology and/or biopsy, the company says. The estimated one-year duration of response rate is 74.6%, adding that 41 of 48 responders (85%) remained in complete response status at the data cutoff (1/2/2024), it adds.

TAR-200 is an investigational drug-device targeted releasing system designed to provide extended local release of gemcitabine into the bladder, J&J says. It is installed in a physician’s office during a three to five minute procedure with no anesthesia. Late last year, FDA granted TAR-200 a Breakthrough Therapy Designation (BTD) for the potential future treatment of patients with BCG-unresponsive HR-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