Drugs

Keytruda ‘Positive’ Data in Cervical Cancer

Merck says its Keytruda (pembrolizumab) plus concurrent chemoradiotherapy reduced the risk of disease progression or death by 30% compared to concurrent chemoradiotherapy alone in treating newly diagnosed patients with high-risk locally advanced cervical cancer. The data come from the Phase 3 KEYNOTE A-18 trial, which is supporting a priority review for a supplemental BLA that is under review and has a 1/20/2024 review action target date, according to the company.

Merck notes that median progression-free survival (PFS) was not yet reached in either group. “The 24-month PFS rate was 67.8% for patients who received the Keytruda regimen compared to 57.3% for those who received concurrent chemoradiotherapy alone,” it says. “In addition to an improvement in PFS, a favorable trend in overall survival (OS), the trial’s other primary endpoint, was observed for the Keytruda regimen versus concurrent chemoradiotherapy alone (HR=0.73 [95% CI, 0.49-1.07]); with only 103 events across both groups, these OS data are not mature and did not reach statistical significance at the time of this interim analysis.”

The trial is continuing and OS follow-up is ongoing, according to Merck. Keytruda’s safety profile was consistent with that observed in previously reported studies, it says, adding that no new safety signals were identified.

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