Drugs

Amgen sNDA on Kyprolis Superiority Data Under FDA Review

FDA has accepted an Amgen supplemental NDA for Kyprolis (carfilzomib) and dexamethasone that includes overall survival (OS) data from the Phase 3 head-to-head ENDEAVOR trial demonstrating that the therapies reduced the risk of death by 21% and increased OS by 7.6 months versus Velcade (bortezomib) and dexamethasone in patients with relapsed or refractory multiple myeloma. The agency has set a user fee review target action date of 4/30/2018. If approved, the sNDA will amend Kyprolis’ U.S. prescribing information to include this data from the ENDEAVOR trial showing that the therapy, administered at the 56 mg dose as a 30-minute infusion twice weekly with dexamethasone, helped relapsed or refractory multiple myeloma patients live longer than patients administered Velcade, according to the company.

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