Drugs

Merck, Eisai Discontinue Melanoma Trial

After an interim analysis showed disappointing data, Merck and Eisai say they are discontinuing the Phase 3 LEAP-003 trial evaluating Keytruda plus Lenvima for first-line treatment of adults with unresectable or metastatic melanoma. The decision is based on an independent data monitoring committee recommendation after it found that the combination did not demonstrate an improvement in overall survival, one of the study’s dual primary endpoints, versus Keytruda alone. The companies note that at an earlier interim analysis, the trial did show improvement in progression-free survival, the trial’s other dual primary endpoint.

In a separate Phase 3 study final analysis, the companies found that the LEAP-017 trial evaluating Keytruda plus Lenvima did not meet its primary endpoint of overall survival for treating patients with unresectable and metastatic colorectal cancer that is mismatch repair proficient or not microsatellite instability-high who experienced disease progression on, or became intolerant to, prior therapy.

Currently, the combination use of the two drugs is approved in the U.S., the EU, Japan and other countries for treating advanced renal cell carcinoma (RCC) and certain types of advanced endometrial carcinoma. Merck and Eisai are studying the combination through the LEAP (LEnvatinib And Pembrolizumab) clinical program in multiple tumor types, including but not limited to endometrial carcinoma, hepatocellular carcinoma, melanoma, non-small cell lung cancer, RCC, head and neck cancer, colorectal cancer, gastric cancer and esophageal cancer, across more than 10 clinical trials.

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