Drugs

NDA Filed for Kura’s Ziftomenib for Rare Leukemia

FDA has accepted for priority review a Kura Oncology NDA for ziftomenib, a potential new treatment for adult patients with relapsed or refractory acute myeloid leukemia (AML) harboring nucleophosmin 1 (NPM1) mutations. Ziftomenib is described as an investigational oral menin inhibitor, and it is the only therapy of its kind to have received Breakthrough Therapy Designation for this patient population, according to the company. The agency has set a user fee review action target date of 11/30.

The NDA submission is supported by positive results from the Phase 2 KOMET-001 clinical trial, which met its primary endpoint of complete remission or remission with partial hematologic recovery in patients with R/R NPM1-mutant AML, Kura says. Data showed that ziftomenib was well-tolerated, with low rates of myelosuppression and only 3% of patients discontinuing treatment due to drug-related effects.

Kura says AML is the most common acute leukemia in adults, while NPM1 mutations occur in about 30% of AML cases and initially respond to therapy. Unfortunately, relapsed patients face poor survival outcomes — particularly in later lines of treatment, 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