Drugs

Positive Keytruda Data in Lung Cancer: Merck

Merck says the Phase 3 KEYNOTE-671 trial evaluating Keytruda (pembrolizumab) as a perioperative treatment regimen for patients with resectable Stage II, IIIA or IIIB non-small cell lung cancer (NSCLC) met its dual primary endpoint of overall survival (OS). During a recent interim analysis, the company says “Keytruda plus chemotherapy before surgery (neoadjuvant), followed by resection and Keytruda as a single agent after surgery (adjuvant), demonstrated a statistically significant and clinically meaningful improvement in OS compared to neoadjuvant placebo plus chemotherapy followed by adjuvant placebo in these patients.”

Merck says the data represent a significant milestone in treating this patient population as it represents the first Phase 3 study to show a statistically significant overall survival benefit. “As previously announced, at the first interim analysis, KEYNOTE-671 met the other one of its dual primary endpoints, event-free survival (EFS), as well as its key secondary endpoints of pathological complete response (pCR) and major pathological response (mPR),” it adds.

The company notes that data from the study is included in a supplemental BLA, which has a review action target date of 10/16.

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