Drugs

FDA Approves Amgen sBLA for Xgeva

FDA has approved an Amgen supplemental BLA for Xgeva (denosumab) to expand the currently approved indication for the prevention of skeletal-related events (SREs) in patients with bone metastases from solid tumors to include patients with multiple myeloma. The approval is based on data from a Phase 3 study that enrolled 1,718 patients.

The study met the primary endpoint, demonstrating non-inferiority to zoledronic acid in delaying the time to first on-study skeletal-related event in patients with multiple myeloma, according to the company. Secondary endpoints, delaying time to first skeletal-related event and delaying time to first-and-subsequent SREs, did not demonstrate superiority. Overall survival was comparable between Xgeva and zoledronic acid, it says.

Xgeva is a human monoclonal antibody that binds to and neutralizes RANK ligand, “a protein essential for the formation, function and survival of osteoclasts, which break down bone — thereby inhibiting osteoclast-mediated bone destruction,” Amgen says. Xgeva is currently indicated for the prevention of SREs in patients with bone metastases from solid tumors based on results from three previous pivotal Phase 3 head-to-head studies.

XGEVA was originally approved by FDA in 2010 for preventing SREs in patients with bone metastases from solid tumors. In 2013, it was approved for adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity.

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