Drugs

Merck Discontinues 2 Keytruda Phase 3 Trials

Merck says it is discontinuing two Keytruda (pembrolizumab) trials — KEYNOTE 867 and KEYNOTE 630. A company statement says the decision to discontinue the trials was based on recommendations from independent data monitoring committees.

The 867 trial was evaluating Keytruda in combination with stereotactic body radiotherapy to treat patients with stage 1 or 2 non-small cell lung cancer, including those who are medically inoperable or have refused surgery, Merck says. It says the data monitoring committee found at the pre-specified interim analysis that the treatment did not demonstrate improvement in event-free survival or overall survival.

The 630 trial evaluated Keytruda as an adjunct treatment of patients with high-risk locally advanced cutaneous squamous cell carcinoma following surgery and radiation. The committee recommended that the trial be stopped for futility, as the risk/benefit profile did not support continuing it, Merck says.

Keytruda is described as an anti-programmed death receptor-1 therapy that works by increasing the ability of the body to help detect and fight tumor cells.

Merck says that on the recommendation of independent data monitoring committees, it is discontinuing a Keytruda lung cancer trial and a cutaneous squamous cell carcinoma trial.

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