Drugs

Subcutaneous Keytruda is Noninferior to IV Formulation: Merck

Merck is reporting “positive topline results” from the pivotal Phase 3 MK-3475A-D77 trial that evaluated the noninferiority of subcutaneous administration of Keytruda (pembrolizumab) and berahyaluronidase alfa, a hyaluronidase variant manufactured by Alteogen administered with chemotherapy versus intravenous (IV) Keytruda administered with chemotherapy for the first-line treatment of adult patients with metastatic non-small cell lung cancer.

“The Phase 3 trial met its dual primary pharmacokinetic (PK) endpoints,” Merck says. “Specifically, subcutaneous pembrolizumab administered every six weeks with chemotherapy demonstrated noninferiority of area under the curve (AUC) exposure of pembrolizumab during the first dosing cycle, and trough concentration (Ctrough) of pembrolizumab measured at steady state, compared to IV Keytruda administered every six weeks in combination with chemotherapy.”

Additionally, the company says secondary endpoints were generally consistent for subcutaneous pembrolizumab compared with the IV formulation. “These results, as well as those from ongoing analyses, will be presented at an upcoming medical meeting and shared with regulatory authorities worldwide,” Merck says.

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