Drugs

Advisory Panel Unanimously Backs New Rituxan Formulation

FDA’s Oncologic Drugs Advisory Committee has voted unanimously (11 to 0) that the benefit-risk ratio of rituximab/hyaluronidase for subcutaneous injection was favorable for treating certain blood cancers, which include: previously untreated follicular lymphoma, previously untreated diffuse large B-cell lymphoma, relapsed or refractory low grade or follicular lymphoma, and previously untreated and relapsed or refractory chronic lymphocytic leukemia. The new co-formulation includes the same monoclonal antibody as intravenous Rituxan (rituximab) and hyaluronidase, a molecule that helps to deliver medicine under the skin. The agency is expected to make its review decision by 6/26.

The panel based its recommendation on a review of data from five studies involving more than 2,000 patients with blood cancers for which intravenous Rituxan is approved. “The studies demonstrated that subcutaneous administration of the co-formulation resulted in non-inferior levels of rituximab in the blood (pharmacokinetics) and consistent clinical efficacy and safety outcomes compared to intravenous Rituxan,” Genentech says.

“Subcutaneous rituximab can be administered in five to seven minutes compared to an hour and a half or more for intravenous Rituxan,” the company says. “The significant reduction in administration time could especially benefit people with blood cancer who may receive years of treatment, and we are pleased the committee unanimously supported this new co-formulation.”

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