Odronextamab for Lymphoma: FDA Delays Approval Decision, Trials Still Enrolling

On March 25th, 2024, Regeneron Pharmaceuticals, Inc. disclosed in a press release that the U.S. Food and Drug Administration (FDA) has requested additional information before deciding whether or not to approve odronextamab for relapsed/refractory follicular lymphoma and in relapsed/refractory diffuse large B-cell lymphoma (DLBCL). 

What Is Odronextamab?

When the immune system works properly, it can identify and kill cancer cells. However, cancer cells often learn how to disguise themselves so the immune system does not recognize them. These cells also weaken the immune system so it can’t control their growth.  Bispecific antibodies are a new type of therapy that helps the immune system to recognize the cancer cells again, and they are revolutionizing blood cancer treatment. 

Bispecific antibodies have two arms: one is drawn to a target protein, such as CD20, located on the lymphoma cell, and the other is drawn to CD3, found on T cells. The idea is that the bispecific antibody can “redirect” T cells to the lymphoma cells, and then the T cells kill them. This is why bispecific antibodies are also known as T-cell engagers or T-cell redirecting therapy.  

Odronextamab is an investigational bispecific antibody that targets lymphoma cells and has shown promising activity in treating patients with lymphoma. In particular, odronextamab is being studied in patients with follicular lymphoma or diffuse large B-cell lymphoma (DLBCL) who have been treated with two or more different treatment types and are not responding to therapy or who responded initially but whose lymphoma is progressing again.

What Information Is the FDA Requesting About Odronextamab?

The FDA started reviewing the available data on odronextamab in September 2023 and predicted that by the end of March 2024, they would announce a decision on its approval for patients with follicular lymphoma or DLBCL. However, they have asked the maker for additional information regarding the status of the open trials with odronextamab.

It is important to clarify that the FDA has not raised any questions about the efficacy, safety, clinical trial design, labeling, or manufacturing of odronextamab. Their request explicitly concerns the number of patients recruited so far in the confirmatory trials under the OLYMPIA program and when they will be completed. However, this will impact the predicted timelines and delay the FDA’s decision on the commercialization of odronextamab.

The European Medicines Agency is also reviewing odronextamab for its commercialization in Europe.

Odronextamab’s Open Clinical Trials

Odronextamab is being investigated in multiple Phase 3 trials within the OLYMPIA program, one of the largest clinical programs in lymphoma treatment. Three clinical trials are recruiting patients with follicular lymphoma, and two are enrolling patients with DLBCL. These trials evaluate the use of odronextamab in different stages of the disease and combine it with other agents to improve its potency against lymphoma cells.

If you are interested in participating in clinical trials and want to know if any are open near you, use our Clinical Trial Finder tool. 

1. Create a HealthTree Cure Hub for follicular lymphoma or DLBCL account.
2. Go to “Clinical Trial Finder” for follicular lymphoma or DLBCL and filter by your location.

Sources:

• REGENERON PROVIDES UPDATE ON BIOLOGICS LICENSE APPLICATION FOR ODRONEXTAMAB
• Bispecific antibodies in cancer therapy: Target selection and regulatory requirements
• Bispecifics antibodies: The next big thing in lymphoma treatment