Drugs

Speedy Approval for Opdivo in Lung Cancer

FDA has approved Bristol Myers Squibb’s Opdivo (nivolumab) 360 mg (injection for intravenous use) for adult patients with resectable non-small cell lung cancer (NSCLC). The approval came five days after the company said the submission was accepted for priority review and having a 7/13 user fee review action target date. The approval covers Opdivo’s use in combination with platinum-doublet chemotherapy every three weeks for three cycles for adult patients in the neoadjuvant setting.

The approval is based on data from the CheckMate -816 trial, which the company describes as the first positive Phase 3 trial of an immunotherapy-based combination used before surgery for resectable NSCLC. The primary endpoints included event-free survival (EFS), pathologic complete response (pCR), and overall survival (OS).

In the trial, the Opdivo regimen showed a statistically significant improvement in EFS with a 37% reduction in the risk of progression, recurrence or death compared to chemotherapy alone, according to the company. Additionally, 24% of patients treated with Opdivo pCR compared to 2.2% of patients treated with chemotherapy alone. Bristol Myers noted that a prespecified interim analysis for OS did not cross the boundary for statistical significance.

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