Drugs

BMS Reports Positive Data in CheckMate-227 Study

Bristol-Myers Squibb (BMS) says that its ongoing Phase 3 CheckMate-227 study met its co-primary endpoint of progression-free survival (PFS) with the Opdivo (nivolumab) plus Yervoy (ipilimumab) combination versus chemotherapy in first-line advanced non-small cell lung cancer (NSCLC) patients whose tumors have high tumor mutation burden (TMB), regardless of PD-L1 expression. PD-L1 is an immunoinhibitory molecule that suppresses the activation of T cells, leading to the progression of tumors. “Additionally, based on an interim analysis for overall survival (OS), the data monitoring committee recommended that the study continue,” it says. The safety profile was consistent with previously reported findings in first-line NSCLC for the combination.

BMS notes that TMB has become an important biomarker for immunotherapy activity. “Over time, cancer cells accumulate mutations that are not seen in normal cells of the body,” it says. The quantitative biomarker reflects the total number of mutations carried by tumor cells. “Tumor cells with high TMB have higher levels of neoantigens, which are thought to help the immune system recognize tumors and incite an increase in cancer-fighting T cells and an anti-tumor response,” the company says.

Opdivo is a programmed death-1 immune checkpoint inhibitor that is designed to harness the body’s own immune system to help restore anti-tumor immune response. It is FDA-approved for treating metastatic melanoma, NSCLC with progression on or after platinum-based chemotherapy, advanced renal cell carcinoma, classical Hodgkin lymphoma, and recurrent or metastatic squamous cell carcinoma of the head and neck, among other indications.

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