Drugs

Replimune BLA Resubmission for Melanoma Therapy

FDA has accepted for review a Replimune BLA resubmission for RP1 (vusolimogene oderparepvec) in combination with nivolumab for treating advanced melanoma in patients whose disease has progressed on an anti–PD-1-based regimen. The agency set a user fee review action target date of 4/10.

The company says the filing includes additional information, data, and analyses to address FDA’s concerns that were raised in an July complete response letter. The letter took issue with Replimune’s supporting clinical trial data, trial design, and the heterogeneous patient population in the Phase 1-2 IGNYTE trial. Issues were also raised about the design of the confirmatory Phase 3 IGNYTE-3 trial, specifically questioning the ability to distinguish the individual benefits of RP1 and nivolumab, according to the company.

RP1 is Replimune’s lead oncolytic immunotherapy candidate. The therapy is based on a genetically modified herpes simplex virus engineered to enhance tumor cell destruction and stimulate a systemic anti-tumor immune response, the company says. It includes genetic modifications for a fusogenic protein and GM-CSF to boost both direct tumor killing and immune activation, it says.

If approved, RP1 in combination with nivolumab could represent a new treatment option for patients with advanced melanoma who have limited therapeutic alternatives following PD-1 inhibitor therapy.

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