Biologics

Replimune BLA for Melanoma Gets Priority Review

FDA has accepted for priority review a Replimune Group BLA for RP1 (vusolimogene oderparepvec) in combination with nivolumab for patients with advanced melanoma. The agency has set a user fee review action target date of 7/22.

The BLA is supported by data from the IGNYTE trial demonstrating that one-third of patients treating with RP1 experienced a “confirmed response, with an overall response rate of 33.6%,” the company says. Approval is being sought under the accelerated approval pathway and a confirmatory Phase 3 trial is currently underway, it says.

RP1’s design was based on a proprietary strain of herpes simplex virus engineered and genetically armed with a fusogenic protein (GALV-GP R-) and a granulocyte-macrophage colony-stimulating factor, which is a white blood cell growth factor that plays a role in the immune system, according to the company. The therapy is intended to “maximize tumor-killing potency, the immunogenicity of tumor cell death, and the activation of a systemic anti-tumor immune response,” it 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