Drugs

FDA Approves BMS’ Opdivo Qvantig Injection

FDA has approved Bristol Myers Squibb’s Opdivo Qvantig (nivolumab and hyaluronidase-nvhy) for subcutaneous injection across approved adult, solid tumor nivolumab (Opdivo) indications as monotherapy, monotherapy maintenance following completion of Opdivo plus Bristol Myers Squibb’s Yervoy (ipilimumab) combination therapy, or in combination with chemotherapy or carbozantinib (Exelixis’ Cabometyx). An agency notice says the approval includes indications for renal cell carcinoma, non-small cell lung cancer, head and neck squamous cell carcinoma, urothelial carcinoma, colorectal cancer, hepatocellular carcinoma, esophageal carcinoma, gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma. Opdivo Ovantig is not indicated in combination with intravenous Yervoy, it says.

Qvantig was evaluated in the CHECKMATE-67T trial of 495 patients, FDA says. The primary objective was to assess the nivolumab exposure of subcutaneous administration of Opdivo Qvantig compared to intravenous nivolumab. The key secondary objective was to evaluate the overall response rate.

In general, FDA says, CHECKMATE-67T showed a similar safety profile between Opdivo Qvantig and intravenous nivolumab. The most common adverse reactions, it says, were fatigue, musculoskeletal pain, pruritis, rash, and cough.

The review was conducted under Project Orbis in association with Health Canada and Israel’s Ministry of Health and used the Assessment Aid.

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