The Food and Drug Administration (FDA) has recently announced the Priority Review of “odronextamab to treat adult patients with relapsed/refractory follicular lymphoma or relapsed/refractory diffuse large B-cell lymphoma (DLBCL), who have progressed after at least two prior systemic therapies.” Priority Review means that the FDA aims to take action on a drug application within six months, compared to 10 months under standard review. This accelerated review is supported by data from the phase 1 ELM-1 and the phase 2 ELM-2 trial. March 31, 2024 is the FDA target decision date for the possible approval of odronextamab.
Odronextamab is an off-the-shelf CD20×CD3 bispecific antibody, meaning that it binds to a cell surface protein called CD3 on T cells and CD20 on B cells, triggering T‐cell‐mediated cell death of the cancerous DLBCL cells. This drug is given intravenously.
Safety among patients has also been evaluated. Some of the adverse effects were as follows:
"The Phase 1 and pivotal Phase 2 odronextamab data demonstrated deep and durable responses that were consistent in patients who progress after CAR-T therapy, which is important as they have particularly difficult-to-treat disease and no effective treatment options. Coupled with its overall safety profile, these clinically important results reinforce the potential of odronextamab to treat this aggressive blood cancer."
The ELM-1 and ELM-2 studies are still ongoing. Regeneron, the pharmaceutical company developing odronextamab, states that they are also initiating a broad Phase 3 development program to investigate odronextamab in earlier lines of therapy and other types of non-Hodgkin lymphomas, representing one of the largest clinical programs in lymphoma.
The Food and Drug Administration (FDA) has recently announced the Priority Review of “odronextamab to treat adult patients with relapsed/refractory follicular lymphoma or relapsed/refractory diffuse large B-cell lymphoma (DLBCL), who have progressed after at least two prior systemic therapies.” Priority Review means that the FDA aims to take action on a drug application within six months, compared to 10 months under standard review. This accelerated review is supported by data from the phase 1 ELM-1 and the phase 2 ELM-2 trial. March 31, 2024 is the FDA target decision date for the possible approval of odronextamab.
Odronextamab is an off-the-shelf CD20×CD3 bispecific antibody, meaning that it binds to a cell surface protein called CD3 on T cells and CD20 on B cells, triggering T‐cell‐mediated cell death of the cancerous DLBCL cells. This drug is given intravenously.
Safety among patients has also been evaluated. Some of the adverse effects were as follows:
"The Phase 1 and pivotal Phase 2 odronextamab data demonstrated deep and durable responses that were consistent in patients who progress after CAR-T therapy, which is important as they have particularly difficult-to-treat disease and no effective treatment options. Coupled with its overall safety profile, these clinically important results reinforce the potential of odronextamab to treat this aggressive blood cancer."
The ELM-1 and ELM-2 studies are still ongoing. Regeneron, the pharmaceutical company developing odronextamab, states that they are also initiating a broad Phase 3 development program to investigate odronextamab in earlier lines of therapy and other types of non-Hodgkin lymphomas, representing one of the largest clinical programs in lymphoma.
about the author
Lisa Foster
Lisa Foster is a mom of 3 daughters, a puzzle lover, a writer, and a HealthTree advocate. She believes in the mission of the foundation and the team that builds it forward. She calls Houston, Texas home.
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