Drugs

Novartis Phase 3 Lung Cancer Trial Doesn’t Hit Endpoints

Novartis says the CANOPY-1 Phase 3 study of canakinumab in lung cancer did not meet its primary endpoints of overall survival and progression-free survival in patients with previously untreated locally advanced or metastatic non-small cell lung cancer. The company says patients in the treatment arm received canakinumab combined with pembrolizumab (Merck’s Keytruda) plus platinum-based doublet chemotherapy, compared to patients receiving placebo in combination with pembrolizumab plus platinum-based doublet chemotherapy.

The company says that while the drug did not meet the primary endpoints, it showed potentially clinically meaningful improvements in both progression-free survival and overall survival in pre-specified subgroups of patients based on biomarkers. “These data support further evaluation of canakinumab in lung cancer,” Novartis says.

Canakinumab is described as a human monoclonal antibody that binds with high affinity and selectivity to human interleukin-1beta and neutralizes its activity by blocking its interaction with its receptors.

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