Drugs

Verastem Reports Positive Phase 3 DUO Results

Verastem is reporting positive top-line results from its Phase 3 DUO study evaluating the efficacy and safety of duvelisib, a first-in-class oral dual inhibitor of phosphoinositide 3-kinase-delta and P13K-gamma in patients with relapsed or refractory chronic lymphatic leukemia/small lymphocytic lymphoma (CLL/SLL). A company announcement says that on the study’s primary endpoint of progression-free survival as determined by an independent review committee, oral duvelisib monotherapy showed superiority over ofatumumab (Novartis’ Arzerra), an approved standard of care treatment for patients with CLL/SLL, achieving a statistically significant improvement in median progression-free survival of 13.3 months, compared to 9.9 months for ofatumumab.

The company says it will share its findings with FDA in hopes of filing an NDA in the first half of 2018. It says the NDA will be supported by favorable results from both the DUO study in CLL/SLL and the DYNAMO study in indolent non-Hodgkin’s lymphoma, which is said to also have achieved its primary endpoint.

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