FDA officials indicated that the confirmatory trial for odronextamab for patients with follicular lymphoma and diffuse large B-cell lymphoma should be under way before resubmission.
The FDA has issued complete response letters (CRLs) for Regeneron’s biologics license application (BLA) for odronextamab in patients relapsed/refractory (R/R) follicular lymphoma (FL) and in R/R diffuse large B-cell lymphoma (DLBC).
Regeneron officials said in a press release that regulators want to address an issue related enrollment status of the confirmatory trial. The company has been actively enrolling patients in multiple phase 3 trials for odronextamab as part of the OLYMPIA program. The program both dose-finding and confirmatory portions. Enrollment in the dose-finding portion has begun, but the CRLs indicate that the confirmatory portions of these trials should be under way and that the timelines to completion be agreed prior to resubmission.
Follicular lymphoma and diffuse large B-cell lymphoma are the two most common subtypes of B-cell non-Hodgkin lymphoma. FL is a slow-growing subtype, and although many patients are responsive to initial treatment, about 20% are expected to relapse within two years. DLBCL is an aggressive subtype, with up to 50% of high-risk patients experiencing progression after first-line treatment.
Odronextamab is an investigational CD20xCD3 bispecific antibody designed to target both CD20 on cancer cells and CD3-expressing T cells.
Related: FDA Sets Review Date for Odronextamab to Treat Blood Cancers
FDA had set a target action date for March 31, 2024. The submission was based on data data from a phase 1 and pivotal phase 2 trial (ELM-1 and ELM-2). In the phase 2 trial with 121 patients with follicular lymphoma, odronextamab resulted in a 82% objective response rate, with 75% achieving a complete response. The phase 2 trial also enrolled 130 with diffuse large B-cell lymphoma. In these patients, odronextamab resulted in a 49% objective response rate, with 31% achieving a complete response.
Cytokine release syndrome was the most common adverse event, and 64% of cases were mild. Discontinuations due to an adverse event occurred in 10% of patients, and there were five deaths due to pneumonia, COVID-19 and pseudomonal sepsis.
FDA Approves Xolremdi for Ultra Rare Immune Disorder
April 29th 2024Xolremdi is the first therapy for WHIM syndrome, which can cause recurrent lung infections and papillomavirus-related warts. It’s available in two doses: 400 mg for an annual cost of $496,400 and 300 mg for an annual cost of $372,300.
FDA Approves Pfizer’s Gene Therapy Beqvez for Hemophilia
April 26th 2024Beqvez (fidanacogene elaparvovec) is priced at $3.5 million, which is on parity with Hemgenix, the first one-time therapy to treat adults with hemophilia B. Pfizer’s warranty will refund insurers and continue to provide coverage for patients if they change insurers.