Odronextamab's FDA approval: Why it failed and how to get the medicine anyway?

Last updated: 03 September 2024

Odronextamab's FDA approval: Why it failed and how to get the medicine anyway?

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Patients with diffuse large B-cell lymphoma (DLBCL) have long needed additional treatment options. Up to 40% of them experience a relapse after standard therapies like chemotherapy and stem cell transplantation 1. In this context, this year's medicine approvals are particularly significant because they provide much-needed alternatives for these patients.

Following the FDA and EMA approvals of Epkinly, it was anticipated that Ordspono (odronextamab) would also receive approval. However, the FDA ultimately rejected odronextamab's application 2.

What does odronextamab's failed FDA approval mean for patients in the USA, and how can you access this treatment without delay? Here’s what you need to know.

What is Ordspono (odronextamab)?

Odronextamab is a CD20xCD3-targeting bispecific antibody. It's indicated for the treatment of relapsed or refractory follicular lymphoma (FL) and diffuse large B-cell lymphoma.

In its mechanism of action, Ordspono is similar to the recently FDA-approved Epkinly. Both medicines mark an evolution in DLBCL and FL treatments. According to experts, they are expected to make a difference particularly for patients who aren't eligible for CAR-T cell therapy or have relapsed after it 3.

Why did the FDA reject odronextamab?

If Ordspono and Epkinly are similar, then you might be wondering why Epkinly got the FDA's green light, while odronextamab failed to secure an FDA approval.

According to the FDA's complete response letters, its rejection of odronextamab was not based on any issues with efficacy or safety. Instead, it was motivated by the fact that odronextamab's confirmatory clinical trials were not far enough along in their enrollment 2. The FDA wanted these trials to be more advanced and have clear completion timelines before they could consider approving odronextamab.

In other words, if the confirmatory trial enrollment issue is addressed, odronextamab's FDA approval may be granted after all. Time will tell if and when this becomes the case.

What were the results of odronextamab's clinical trials?

Odronextamab's FDA approval and EMA approval applications were backed up by results from the Phase 2 ELM-2 trial and the Phase 1 ELM-1 trial. The key reported highlights from these trials are listed below.

ELM-1 trial:

  • 51% of patients treated with Ordspono had a partial or complete response to the treatment;

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    37% of patients treated with Ordspono had a complete response to the treatment 2.

ELM-2 trial:

  • 52% of DLBCL and 82% of FL patients treated with Ordspono had a partial or complete response to the treatment;
  • 31% of DLBCL and 75% of FL patients had a complete response to the treatment, with a median complete response duration of 18 months and 20.5 months, respectively;
  • The median progression-free survival for FL patients was 20 months 4.

Does odronextamab have EMA approval?

Not yet, but it will soon. Despite ordonextamab's failed FDA approval, the CHMP in Europe made a positive recommendation in June 2024 to approve the medicine in the EU 5. While it typically takes a couple of months for a CHMP recommendation to turn into an official EU marketing authorization, there is no doubt that odronextamab will be approved in Europe by late September 2024.

Is odronextamab available in the UK?

As of September 2024, Ordspono (odronextamab) is not yet approved in the UK. An assessment by NICE for the potential inclusion of the medicine on the NHS is also not underway. While this doesn't necessarily mean that odronextamab will be unavailable in the UK, it does indicate that a UK approval might take some time.

After Brexit, the MHRA reserves the right to grant "near automatic" approval to medicines after they've been green-lit by the EMA or other trusted regulatory bodies 6. Therefore, at least in theory, the UK approval of odronextamab may follow shortly after the medicine's official EMA approval.

How to get odronextamab before its FDA approval

If you're a patient in the USA or elsewhere in the world where odronextamab's approval status is unclear, don't despair. Waiting for an FDA approval or a decision from another local body is not necessary for you to start your treatment.

As soon as odronextamab has an approval somewhere in the world (in this case - the EU), you can access it anywhere else via Named Patient Import.

Buy odronextamab as a Named Patient

Not all patients and doctors know that, but you are allowed to buy and import locally unavailable medicines for personal use. Especially if these medicines could improve your quality of life or address life-threatening conditions.

If you want to get odronextamab before its FDA approval, this might be the quickest option for you and your doctor.

The regulation that makes this possible is known as the Named Patient Import regulation. To qualify for it, you first need to have a prescription from your treating doctor for a medicine that:

  • is approved elsewhere;

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    is not approved or available where you live;

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    has no local alternatives, and

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    is for personal use only.

Already have a prescription? Share it with our team at Everyone.org and we will support you with buying odronextamab immediately.