FDA Accepts BLA Resubmission for Follicular Lymphoma Drug, Odronextamab

The FDA has accepted the resubmitted biologics licensing application (BLA) for Ordspono (odronextamab), with a target action date for the FDA decision by July 30, 2025, according to a recent news release.

The FDA had issued a complete response letter in May 2024 for a previous BLA. In that letter, the FDA asked odronextamab’s manufacturer Regeneron to accelerate patient trial enrollment in the Olympia phase 3 confirmatory trials.

Odronextamab is intended to treat patients with relapsed/refractory (R/R) follicular lymphoma (FL) and patients with diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy. Odronextamab is an investigational bispecific antibody designed to target both CD20 on cancer cells and CD3-expressing T cells.

Follicular lymphoma and diffuse large B-cell lymphoma are two of the most common subtypes of B-cell non-Hodgkin lymphoma (B-NHL), with about 122,000 cases diagnosed every year across the globe. More than 13,600 of those cases are anticipated in the United States this year. Follicular lymphoma is slow growing but incurable and about 20% of patients are expected to relapse within the first two years of treatment. DLBCL is more aggressive, with up to 50% of patients seeing disease progression after first-line treatment. Due to this complexity, odronextamab is being investigated as a monotherapy and as a form of combination therapy.

Odronextamab efficacy was demonstrated during ongoing phase 1 and phase 2 trials (ELM-1 and ELM-2), which showed that it had an overall response rate of 80% (n=103) with 74% (n=95) of patients achieving a complete response. The primary endpoint was measured according to the Lugano Classification, which is a five-stage scale that measures lymphoma spread.

The most common adverse reaction (54%) was cytokine release syndrome (CRS), which occurs when the immune system responds more aggressively than it should to an infection or immunotherapy, causing fever, chills and in extreme cases, death. Other reactions include neutropenia (41%) and pyrexia (39%). All results were published in the Annals of Oncology in November 2024.

Odronextamab is already approved in the European Union as Ordspono for the treatment of R/R FL or DLBCL after two or more lines of systemic therapy.