Drugs

Favorable Data on Keytruda in Lung Cancer

Merck says new data from the pivotal Phase 3 KEYNOTE-091 trial found that adjuvant treatment with Keytruda significantly improved disease-free survival (DFS), one of the dual primary endpoints, reducing the risk of disease recurrence or death by 24% compared to placebo in patients with stage IB to IIIA non-small cell lung cancer following surgical resection regardless of PD-L1 expression. Median DFS was 53.6 months for Keytruda versus 42.0 months for placebo.

The other dual endpoint, an improvement in DFS for patients whose tumors express PD-L1, did not reach statistical significance under the pre-specified statistical plan, the company says. “Among these patients, median DFS was not reached in either arm,” it says. “Additionally, a favorable trend in overall survival (OS), a key secondary endpoint, was observed for Keytruda versus placebo regardless of PD-L1 expression.” Merck also notes that the OS data are not mature and did not reach statistical significance at the time of the current interim analysis. The trial will continue to assess DFS in patients whose tumors express high levels of PD-L1 and OS, 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