Odronextamab
- Generic Name
- Odronextamab
- Brand Names
- -
- Drug Type
- Biotech
- Chemical Formula
- -
- CAS Number
- 1801338-64-6
- Unique Ingredient Identifier
- 8R5CM46UIO
- Background
Odronextamab is a hinge-stabilized, fully human immunoglobulin G4 (IgG4)-based CD20×CD3 bispecific antibody currently evaluated for the treatment of relapsed/refractory (R/R) B-Cell non-Hodgkin lymphoma (NHL). Preliminary studies have shown that in patients with R/R NHL, the use of odronextamab does not lead to the development of neurologic toxicity; however, it can lead to the development of cytokine release syndrome (CRS), a serious condition associated with the use of immunotherapy. In December 2020, the FDA placed a partial clinical hold and requested the drug developer, Regeneron Pharmaceuticals, to amend clinical protocols to reduce the incidence of CRS. The partial clinical hold was later lifted in May 2021.
A phase I clinical study (NCT02290951) showed that in heavily pre-treated patients with B-cell non-Hodgkin lymphoma, odronextamab elicited a durable response with a manageable safety profile.
- Associated Conditions
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- Associated Therapies
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When Are Confirmatory Trials ‘Underway’? FDA Releases New Accelerated Approval Guidance
The FDA issued guidance clarifying requirements for confirmatory trials in accelerated approvals, emphasizing trials must be 'underway' with enrollment started and measurable progress. It addresses delays in follow-up studies, especially for rare diseases, suggesting non-randomized trials may suffice. The guidance aims to ensure timely completion of trials, critical for the program's integrity.
Upcoming changes to the list of specialty drugs that will require precertification
Starting January 1, 2025, Independence Blue Cross updates specialty drugs requiring precertification for certain plans. Includes FDA-approved drugs like Ahzantive, Bkemv, and pending approval drugs. Updates also reflect brand name changes for previously added drugs.
Odronextamab: What is it and is it FDA approved?
Odronextamab, by Regeneron Pharmaceuticals, is an investigational CD20xCD3 bispecific antibody for treating relapsed/refractory follicular lymphoma and diffuse large B-cell lymphoma. Despite a BLA submission, FDA issued CRLs due to trial enrollment issues, not efficacy or safety concerns. It holds Orphan Drug and Fast Track Designations.
Study points to weaknesses in FDA accelerated approval path
A study found less than half of FDA-accelerated approved cancer therapies (2013-2017) showed clinical benefits in confirmatory trials within five years. Despite 63% converting to full approval, only 43% demonstrated benefits in survival or quality-of-life. Concerns were raised about reliance on surrogate measures and the need for timely, evidence-based conversion decisions.
FDA looks to clarify confirmatory trial mandate for accelerated approvals
The FDA clarified its stance on confirmatory trials for accelerated drug approvals, defining 'underway' as trials with a target completion date, measurable progress, and started enrollment. Flexibility is maintained, with some trials possibly not needing to be underway at approval. The guidance aims to ensure timely trial completion and clinical benefit verification.
Odronextamab ASH Presentations Underscore Impressive Potential in Lymphoma Treatments
Odronextamab showed complete responses in untreated follicular lymphoma patients in the OLYMPIA-1 trial, durable responses in DLBCL post-CAR-T therapy in ELM-1, and high complete response rates in relapsed/refractory MZL in ELM-2. Safety profiles were manageable across trials.
2024 FDA Approvals
In 2024, the FDA approved 50 new drugs, focusing on cancer, with 15 approvals. Small molecules led with 32 approvals, followed by proteins and oligonucleotides. Notable approvals included a schizophrenia treatment and a NASH drug, marking significant advancements in therapeutic areas.
Odronextamab ASH Presentations Underscore Impressive Potential in Earlier Lines of Treatment and Additional Types of Lymphoma
Odronextamab showed complete responses in all evaluable patients with untreated follicular lymphoma in the OLYMPIA-1 trial. ELM-1 trial data revealed durable responses in DLBCL post-CAR-T therapy. ELM-2 trial demonstrated high complete response rates in relapsed/refractory marginal zone lymphoma. Presented at ASH 2024.
5 Key Drug Approvals and CRLs in 2024
In 2024, FDA issued CRLs for MDMA in PTSD and several cancer drugs due to manufacturing issues. Biosimilars for aflibercept and denosumab were approved, including first interchangeables. Two drugs for Niemann-Pick disease type C and a novel schizophrenia treatment targeting cholinergic receptors were also approved.
Prior CAR T-Cell Therapy Exposure May Impact Odronextamab Benefit in DLBCL
Odronextamab combinations may help elicit responses in DLBCL patients after CAR T-cell therapy failure. Duration of prior CAR T-cell therapy benefit predicts bispecific antibody response. Developing combination approaches with odronextamab aims to mitigate disease progression and elicit responses.
Drug Development Updates
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