Drugs

Glaxo Lung Cancer Phase 2 Trial Meets Endpoint

GlaxoSmithKline says the Phase 2 PERLA trial evaluating its dostarlimab (Jemperli) plus chemotherapy versus pembrolizumab (Merck’s Keytruda) plus chemotherapy in first-line patients with metastatic non-squamous, non-small cell lung cancer met its primary endpoint of objective response rate. A company statement says the trial was not designed to demonstrate superiority.

GSK says the safety and tolerability profile of Jemperli in the PERLA Phase 2 trial was consistent with previous clinical trials of similar regimens. It says the most common treatment-emergent adverse reactions were anemia, asthenia, nausea, constipation, cough, dyspnoea, vomiting, decreased appetite, and neutropenia.

The company also said it is moving both arms of the COSTAR Lung trial into Phase 3 on the recommendation of the independent data monitoring committee since the trial met its pre-specified expansion criteria per protocol. The trial compares cobolimab, an investigational selective anti-TIM-3 monoclonal antibody, plus dostarlimab plus docetaxel to dostarlimab plus docetaxel to docetaxel alone in patients with advanced non-small cell lung cancer who have progressed on prior anti-PD-1 therapy and chemotherapy.

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