Drugs

FDA Accepts 2 Opdivo sBLAs for New Indications

FDA has accepted two Bristol-Myers Squibb sBLAs for new indications for its Opdivo (nivolumab). The first sBLA is to treat patients with resected esophageal or gastroesophageal junction cancer in the adjuvant setting, after neoadjuvant chemoradiation therapy. The agency granted the application priority review and set a PDUFA goal date of 5/20.

The company says its filing was based on results from the Phase 3 CheckMate-577 trial, the first trial to show positive results in the adjuvant setting in this group of patients. The study met its primary endpoint of disease-free survival in patients with the two types of cancer.

The second sBLA was for Opdivo in combination with fluoropyrimidine- and platinum-containing chemotherapy to treat patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer, or esophageal adenocarcinoma. This application also was granted priority review and has a PDUFA goal date of 5/25. This submission was based on data from the CheckMate-649 Phase 3 trial, BMS 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