Linvoseltamab's approval by the EMA (and FDA): How long will you have to wait?

Multiple myeloma (MM) is the second most common blood cancer. Every year, over 176,000 new cases are diagnosed around the world. Although there are treatments available that can slow the progression of the disease, the condition is not yet curable. 

That's why the possibility of a new MM treatment getting approved is positive for patients and doctors everywhere. Linvoseltamab has submitted its marketing authorization application to both the FDA (with priority review) and EMA. Now it's just a matter of time until it gets its approval and becomes available to patients. 

Here's everything you need to know about linvoseltamab's pending FDA and EMA approvals, including timelines and all your options in the meantime.

How does linvoseltamab (BCMAXCD3) work for multiple myeloma?

Linvoseltamab is a B-cell maturation antigen (BCMA) and CD3-targeting bispecific antibody ¹.

In other words, it's designed to help the immune system fight cancer. It works by attaching to two different targets: BCMA (especially the cancerous plasma cells in conditions like multiple myeloma), and CD3 (a protein on T-cells in the immune system). By connecting these two types of cells, linvoseltamab helps the immune system find and kill the cancer cells more effectively.

Linvoseltamab with dupixent (dupilumab) for severe allergy

In addition to treating multiple myeloma, linvoseltamab could also potentially play a role in reversing severe food allergies, in a novel treatment approach that combines linvoseltamab with dupixent (dupilumab). 

According to early data from a Phase 1 trial, the combination of linvoseltamab and dupixent can permanently eliminate Immunoglobulin E (IgE) - a key driver of allergic reactions produced consistently by long-lived plasma cells. A Phase 2 clinical trial looking further into this treatment regimen is set to begin in 2024 ². 

How effective is linvoseltamab in clinical trials?

In April 2024, Regeneron Pharmaceuticals announced the results from the Phase 1/2 LINKER-MM1 trial of linvoseltamab in patients with relapsed/refractory (R/R) multiple myeloma (MM) ³.

Here are some of the key results:

• 71% of patients treated with linvoseltamab had a partial or complete response to the treatment;
• The median time to response was 1 month;
• At 12 months after start of treatment, the estimated probability of maintaining a response was 78%, being progression free was 69% and survival was 75% ³.

These results were the basis for accepting linvoseltamab's FDA and EMA approval applications. A confirmatory Phase 3 clinical trial is currently underway.

Is linvoseltamab (BCMAXCD3) approved anywhere?

As of June 2024, no. Linvoseltamab's approval applications are under review in:

• The USA (with priority assessment) ³;
• The EU ⁴.

When will linvoseltamab get EMA approval?

Typically, decisions on EMA approval take up to 210 days, excluding any pauses to request additional data from the medicine's manufacturer. 

Linvoseltamab has been under review by the EMA since 1st February 2024, meaning that it's theoretically possible it gets EMA approval towards the end of 2024. 

When will linvoseltamab be available in Europe?

Unfortunately, getting EMA approved is only the first step to becoming available for patients. After EMA approval, it takes each member state a different amount of time to negotiate local prices, reimbursements, and launch a new medicine on the local market. Germany's launch process tends to be the fastest, with an average of 100 days for oncological drugs. At the other end of the spectrum is Romania, where it can take up to 964 days on average for a new cancer medicine to become available.

This means that linvoseltamab will become available to you at a different time, depending on where in Europe you are based ⁵.

When will linvoseltamab be approved in the UK?

That's more difficult to say. As of June 2024, there is no marketing authorization submitted to the MHRA for linvoseltamab (BCMAXCD3). Also, no review has been initiated by NICE for the potential inclusion of the medicine on the NHS.

However, according to post-Brexit regulations, the MHRA can decide to approve medicines locally as soon as they get the green light from another trusted regulatory body (such as the EMA or FDA). This is known as the International Reliance Procedure ⁶. It wouldn't be surprising if the MHRA decides to take this road for approving linvoseltamab.

When will linvoseltamab be available in the UK?

If the MHRA approves linvoseltamab simultaneously with the EMA, expected towards the end of 2024, the medicine will then require a NICE assessment before becoming available to patients in the UK. NICE will decide whether to make linvoseltamab available on the NHS. If approved, the medicine should be available to UK patients within three months of the decision date.

Assuming a best-case scenario, where the MHRA follows a potential EMA approval in late 2024, and NICE makes a positive decision soon after, linvoseltamab (BCMAXCD3) could be available in the UK by mid-2025. Only time will tell if such a timeline is indeed realistic.

How to get linvoseltamab before it's available in your country

Despite what the timelines above suggest, waiting is not the only option for multiple myeloma patients in Europe, the UK, or anywhere else.

As soon as linvoseltamab gets an approval somewhere, you can immediately access the medicine anywhere else by importing it for your personal use. This option is known as Named Patient Import, or expanded access. Here's how it works.

Linvoseltamab (BCMAXCD3) expanded access

Even if a medicine is not yet approved or available in your country, you can legally access it. A regulation known as Named Patient Import allows you to buy and import a medicine, as long as it meets these conditions:

• it is approved somewhere;
• it is not approved or available in your country (yet);
• it has no local alternatives, and
• it is for personal use.

This process requires a prescription from your treating doctor. As in all other cases, the doctor assumes responsibility for the treatment. Per country, specific documentation requirements can vary.

Do you want to start your treatment with linvoseltamab as soon as possible, using the Named Patient Import regulation? You will first need to consult your treating doctor and get a suitable prescription.

Already have a prescription? Share it with our team at Everyone.org. We can support you with buying linvoseltamab (BCMAXCD3) as soon as it's approved somewhere in the world.

References:

1. FDA Grants Priority Review to Linvoseltamab for Relapsed/Refractory Multiple Myeloma. OncLive, 21 February 2024.
2. REGN Corporate Presentation. Investor Relations | Regeneron Pharmaceuticals Inc., Accessed 11 June 2024.
3. Linvoseltamab Pivotal Data Presented at AACR Reinforce High Response Rate that Deepens Over Time in Patients with Heavily Pre-Treated Multiple Myeloma. Investor Relations | Regeneron Pharmaceuticals Inc., 7 April 2024.
4. Linvoseltamab Receives EMA Filing Acceptance for Treatment of Relapsed/Refractory Multiple Myeloma. Investor Relations | Regeneron Pharmaceuticals Inc., 2 February 2024.
5. EFPIA Patients W.A.I.T. Indicator 2021 Survey, IQVIA, Accessed 10 June 2024.
6. Fast-Tracking Approval of Medicines - UK Publishes Detailed Guidance on its New International Recognition Procedure. Inside EU Life Sciences, 11 September 2023.