Drugs

Deciphera Pharma Planning NDA for Vimseltinib

Deciphera Pharmaceuticals says it will file an NDA in the second quarter of 2024 for vimseltinib for treating patients with tenosynovial giant cell tumor (TGCT) based on just-announced “positive top-line results” from the MOTION pivotal Phase 3 study of the drug in patients with TGCT not amenable to surgery.

“TGCT has a significant negative impact on the daily life of patients who face substantial pain, stiffness, and impaired mobility,” the company says. “Success across both the primary and all key secondary endpoints in MOTION underscores vimseltinib’s ability to help TGCT patients feel and function better. The top-line results from MOTION, together with the impressive data announced today from the Phase 1/2 study showing that the response rates with vimseltinib continue to increase over time, and that patients continue to receive long-term clinical benefit as evidenced by the median duration of treatment, demonstrates vimseltinib’s potential to become a best-in-class agent.”

Deciphera says the therapy met its primary endpoint in the intent-to-treat (ITT) population in the MOTION study, demonstrating statistically significant and clinically meaningful improvement versus placebo in the objective response rate (ORR) at week 25. “In the ITT population, the ORR at Week 25 was 40% (95% CI: 29%, 51%) for the vimseltinib arm and 0% (95% CI: 0%, 9%) for the placebo arm resulting in a response difference (vimseltinib versus placebo) of 40%,” it adds.

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