Drugs

J&J Touts Bladder Cancer Data in Recent NDA

Johnson & Johnson says data from the Phase 2b SunRISe-1 study evaluating TAR-200, an intravesical gemcitabine releasing system, for patients with certain types of bladder cancer. “These first results show the promise of TAR-200 in this patient population with more than an 80% disease-free survival (DFS) rate without the need for reinduction and 94% of patients able to preserve their bladder,” a company release says. “The high DFS and bladder preservation rate combined with the well-tolerated safety profile in these patients with Bacillus Calmette-Guérin (BCG)-unresponsive, high-risk non-muscle-invasive bladder cancer (HR-NMIBC) with papillary-only disease (high-grade Ta or T1) show the potential of TAR-200 as a meaningful alternative to surgery.”

The data release follows the company’s January NDA submission of TAR-200, which is being reviewed under the agency’s Real-Time Oncology Review program. At the time of submission, the company noted that the therapy 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.

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.

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

Read more

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