Biologics

FDA Accepts Replimune's Resubmitted BLA for Advanced Melanoma

FDA has accepted for review Replimune's BLA resubmission that is seeking accelerated approval of RP1 (vusolimogene oderparepvec) in combination with nivolumab for treating advanced melanoma, the company announced Friday. The agency classified the filing as a Class 1 resubmission and set a review action target date of 8/2. The company was also told to expect an advisory committee meeting in late July to discuss the application.

The resubmission follows FDA's April complete response letter rejecting the application, which is supported by data from the Phase 2 IGNYTE trial evaluating RP1 in combination with nivolumab in patients with advanced melanoma whose disease had progressed after prior anti-PD-1 therapy. The agency declined to approve RP1 despite clinical trial results showing tumor shrinkage or disappearance in roughly one-third of patients. The decision, together with several other high-profile regulatory setbacks issued this spring, drew criticism from industry groups and investors, who argued the agency had become less predictable under former FDA commissioner Marty Makary and the Trump administration. (see earlier story).

The agency reportedly had previously warned Replimune that its single-arm trial design could jeopardize approval. Still, the decision drew heightened scrutiny because it occurred amid internal upheaval at FDA during Makary’s tenure. Makary publicly defended the rejection and accused Replimune of engaging in “corporate spin” after criticism emerged following the decision.

RP1 is a genetically engineered virus designed to destroy tumor cells and stimulate immune activity alongside the immunotherapy drug Opdivo.

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