Drugs

FDA Approves Amgen sNDA for Kyprolis

FDA has approved an Amgen supplemental NDA for Kyprolis (carfilzomib) for injection in combination with dexamethasone or with lenalidomide plus FDA has approved an Amgen supplemental NDA for Kyprolis (carfilzomib) for injection in combination with dexamethasone or with lenalidomide plus dexamethasone for treating patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy. The agency also approved Kyprolis as a single agent for treating patients with relapsed or refractory multiple myeloma who have received one or more lines of therapy. This approval converts to full approval the initial accelerated approval Kyprolis received in 2012 as a single agent.

Approval is based on data from the Phase 3 head-to-head ENDEAVOR study, a superiority trial in which the primary endpoint was progression-free survival (PFS). Data showed that patients with relapsed multiple myeloma treated with Kyprolis and dexamethasone achieved 50% greater PFS of 18.7 months compared to 9.4 months in those receiving Velcade (bortezomib) and dexamethasone, a current standard of care in relapsed multiple myeloma, the company says.

The new indication for Kyprolis is the second in six months. In July, the agency approved another expanded indication for Kyprolis in combination with lenalidomide and dexamethasone for treating patients with multiple myeloma who have received one to three prior lines of therapy.

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