Drugs

FDA Lifts Hold on Kura Leukemia Trial

FDA has lifted a partial clinical hold on a Kura Oncology Phase 1b study (KOMET-001) of KO-539 in patients with relapsed or refractory acute myeloid leukemia (AML). The hold was the result of the company’s recent report to the agency about a Grade 5 serious adverse event (patient death) “potentially associated with differentiation syndrome, a known adverse event related to differentiating agents in the treatment of AML,” according to the company. KO-539 is described as a potent and selective menin inhibitor.

Kura says the hold was lifted following agreement with FDA on the company’s mitigation strategy for differentiation syndrome. “Activities to resume patient screening are underway, and we look forward to expediting enrollment of patients in the Phase 1b study and determining the recommended Phase 2 dose for KO-539 in the coming months,” it says. “Meanwhile, we continue to be encouraged by the safety, tolerability and clinical activity observed among currently enrolled patients and look forward to sharing a comprehensive update on the Phase 1 study at a future medical meeting.”

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