Drugs

BMS Reports Positive Opdivo plus Yervoy Data

Bristol Myers Squibb says data from the Phase 3 CheckMate-9DW trial evaluating the dual immunotherapy combination of Opdivo (nivolumab) plus Yervoy (ipilimumab) compared to investigator’s choice (lenvatinib or sorafenib) as a first-line treatment for patients with unresectable hepatocellular carcinoma (HCC) showed that the combination had a statistically significant and clinically meaningful improvement in the primary endpoint of overall survival (OS). The company says “Median OS was 23.7 months (95% CI: 18.8–29.4) for Opdivo plus Yervoy compared to 20.6 months (95% CI: 17.5–22.5) with lenvatinib or sorafenib (HR: 0.79 (0.65–0.96); p = 0.018).”

The data also showed, Bristol Myers says, a statistically significant improvement in the key secondary endpoint of objective response rate (ORR), which was 36% for the combination treatment compared to 13% with lenvatinib or sorafenib. And there was a higher complete response rate of 7% for Opdivo plus Yervoy compared with 2% for those taking lenvatinib or sorafenib, it adds.

Additionally, the safety profile for the combination remained consistent with previously reported data and was manageable with established protocols, according to Bristol Myers Squibb. “Treatment-related adverse events (TRAEs) of any grade were reported in 84% of patients with Opdivo plus Yervoy and 91% in patients with lenvatinib or sorafenib,” it 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