Drugs

Pragmatica-Lung Study Launches

The National Cancer Institute (NCI) says it has helped to launch a Phase 3 trial of a two-drug combination to treat patients with advanced non-small cell lung cancer (NCSLC). An NCI announcement says the Pragmatica-Lung Study is part of a broader effort by FDA and the National Institutes of Health to modernize clinical trials.

“Pragmatic clinical trials have fewer and simpler eligibility criteria than conventional trials,” the notice says, “while still ensuring the safety of patients. The hope is that this type of simplified trial can be less burdensome to patients and investigators, accrue study participants faster, be more representative of the real-world patient population, and serve as a model for future clinical trials.”

The trial will evaluate whether a combination of Lilly’s Cyramza (ramucirumab) and Merck’s Keytruda (pembrolizumab) improves overall survival over standard treatment in people with advanced NSCLC whose disease has progressed after previous treatment with immunotherapy and chemotherapy. It will enroll up to 700 participants around the U.S.

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