Drugs

FDA Approves Hepzato for Uveal Melanoma

FDA has approved Delcath Systems’ Hepzato Kit (melphalan for injection/hepatic delivery system) for liver-directed treatment in adult patients with uveal melanoma with unresectable hepatic metastases affecting less than 50% of the liver and no extrahepatic disease, or extrahepatic disease limited to the bone, lymph nodes, subcutaneous tissues, or lung that is amenable to resection or radiation.

Approval is based on data from the FOCUS study, a single-arm, multicenter, open-label trial in 91 patients with uveal melanoma with unresectable hepatic metastases, according to an FDA news release. “The main efficacy outcome measures were objective response rate (ORR) and duration of response (DoR) as assessed by an independent central review committee using RECIST v1.1,” it says. “ORR was 36.3% (95% CI: 26.4, 47) and median DoR was 14 months (95% CI: 8.3, 17.7).”

The agency says the drug was approved with Boxed Warning for severe peri-procedural complications including hemorrhage, hepatocellular injury, and thromboembolic events. “The prescribing information also has a Boxed Warning for myelosuppression with resulting severe infection, bleeding, or symptomatic anemia,” it says, adding that a Risk Evaluation and Mitigation Strategy called the Hepzato kit REMS was required.

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