Biologics

Regeneron Odronextamab BLA Rejected Again

FDA has issued Regeneron a second complete response letter (CRL) on its BLA for odronextamab, a bispecific antibody targeting CD20 and CD3 in relapsed/refractory follicular lymphoma after two or more lines of systemic therapy. In a financial update, the company says the submission was rejected over inspection concerns at a Catalent Indiana (recently acquired by Novo Nordisk) manufacturing facility.

Novo has addressed the issues with FDA and expects to submit its inspection response next week, according to Regeneron. Because of the inspection issues, the company now expects regulatory approvals to be delayed for its currently pending FDA applications for Eylea HD (pre-filled syringe, every-four-week dosing, and for the treatment of macular edema following retinal vein occlusion), which have user fee review target dates later this month.

The first odronextamab CRL was issued 3/2024 after the agency determined that there was insufficient enrollment progress in the confirmatory OLYMPIA-1 trial. Regeneron addressed that concern, and the agency agreed to review the resubmission earlier this year.

The resubmission is based on data from the Phase 1 and pivotal Phase 2 trials (ELM-1 and ELM-2), which demonstrated an “overall response rate of 80% (n=103), with 74% (n=95) achieving a complete response,” Regeneron says. Serious adverse events occurred in 67% of patients, it says, including cytokine release syndrome, Covid-19 and pneumonia.

Follicular lymphoma is one of the most common subtypes of B-cell non-Hodgkin lymphoma, according to the company, adding that it is an incurable disease and most patients will relapse after initial treatment.

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