How to navigate Blenrep's withdrawal from the EU and US markets

Once it was considered a "first-of-its-kind" treatment for heavily pretreated multiple myeloma patients. But 2023 and 2024 have not been Blenrep's best years ¹. After initial accelerated approval by the FDA and conditional marketing authorization by the EMA, the medicine was taken off the market both in the USA and the EU in 2024 ^2,3.

What does Blenrep's withdrawal mean to you as a patient? What are some of your alternatives, and could Blenrep make a comeback as a combination therapy? Here's what you should know.

Why was Blenrep taken off the market?

Blenrep (belantamab mafodotin) was taken off the market in the EU and the USA after a confirmatory Phase 3 trial (DREAMM-3) failed to confirm its benefits. More specifically, trial data did not show that Blenrep was more effective than standard treatments in prolonging progression-free survival ⁴.

Is Blenrep still available in the UK?

Since Brexit, the UK is not directly bound by the EMA's approval or withdrawal decisions. According to the MHRA's website, as of August 2024, Blenrep is still authorized for use as monotherapy in the UK ⁶. However, a reassessment of the medicine's UK approval is underway ⁷.

For the time being, patients in the UK may still be able to access Blenrep. However, the medicine is not available on the NHS, as per NICE's draft guidance. The NICE's decision has been appealed. However, a reevaluation is currently paused until the MHRA decides the fate of Blenrep's approval in the UK.

Is Blenrep hazardous?

As with any medicine, there can be adverse affects associated with Blenrep. Some of them, though rare, can be quite serious - including eye problems ⁵.

However, Blenrep's withdrawal was not related to its potential adverse effects. The decision to take it off the market was a result of insufficient evidence of the medicine's efficacy.

Will Blenrep be available again?

Although Blenrep's approval has been withdrawn in the USA and EU, that only applies to its use as monotherapy.

Results from the Phase 3 DREAMM-7 trial showed that Blenrep, when combined with Velcade and dexamethasone, may lower the risk of disease progression or death by 59%. This is in comparison with Darzalex in the same combinations ⁸.

In the phase 3 DREAMM-8 study, Blenrep in combination with Pomylast and dexamethasone lowered the risk of cancer progression or death by 48%. Again, this was in comparison with Velcade in the same combinations ⁸.

These results have been the basis for a new EMA approval application, this time for Blenrep as part of a combination therapy. The application is currently under review and a decision should be made by mid-2025 ⁹. If the EMA gives Blenrep its green light again, it should be available again before the end of 2025 (at least in some European markets).

Blenrep alternatives to discuss with your doctor

Blenrep's withdrawal from the EU and US markets has left patients like you in need of alternative treatment options.

Only your doctor is competent to choose the right Blenrep alternative in your case. Here, we're simply offering a shortlist of medicines approved for multiple myeloma, which you may want to discuss with your doctor:

• Tecvayli (teclistamab-cqyv): Tecvayli is a medicine for heavily pretreated multiple myeloma which has returned after at least four rounds of systemic therapy. It's approved by the FDA and the EMA. Is Tecvayli not available in your country? Get in touch with our team for help with accessing it.

• Talvey (talquetamab-tgvs): Similar to Tecvayli, this medicine is intended for adults with relapsed or refractory multiple myeloma, after at least four rounds of treatment. It's approved by the FDA and the EMA. Get in touch with our team if you need help accessing it in other countries.

• Elrexfio (elranatamab--bcmm): Elrexfio is intended for adults with relapsed or refractory multiple myeloma, after at least four rounds of treatment. Like Tecvayli and Talvey, it's approved by the FDA and the EMA. To access it elsewhere, get in touch with our team.

• Aphexda (motixafortide): Indicated in combinatio with filgrastim, Aphexda helps mobilize hematopoietic stem cells to the peripheral blood for collection and transplantation. Aphexda is only approved in the USA at this moment. However, we can help you access it anywhere if it's prescribed by your doctor.

   

Can you still access Blenrep after its withdrawal?

If you've been treated with Blenrep and had beneficial results, you may not be interested in Adakveo alternatives. Instead, you’re probably wondering if you can still buy belantamab mafodotin after it's been pulled off the market.

The good news is, you can, as long as your doctor maintains the opinion that Blenrep is the right course of treatment for you.

When a medicine is unapproved in a patient's country, or it's approved but not available, you can access it via the Named Patient Import regulation.

Everyone.org specializes in helping people access the latest medicines via this regulation. If you have a prescription from your treating doctor for Blenrep (belantamab mafodotin) and would like us to help you access the medicine immediately, contact us.

References:

1. Blow after ‘first-of-its-kind treatment’ knocked back by NICE. Myeloma UK, Accessed 27 August 2024.
2. Withdrawal of Blenrep from the US Market. International Myeloma Foundation, 23 November 2022.
3. EMA recommends non-renewal of authorisation of multiple myeloma medicine Blenrep. European Medicines Agency, 15 September 2023.
4. GSK provides an update on Blenrep (belantamab mafodotin-blmf) US marketing authorisation. GSK, 22 November 2022.
5. Nguyen, Victor. Blenrep: Cost, side effects, how it works, and more. MedicalNewsToday,  Accessed 27 August 2024.
6. Orphan register. GOV.UK, Accessed 27 August 2024.
7. Project information | Belantamab mafodotin for treating relapsed or refractory multiple myeloma after 4 or more therapies [ID2701] | Guidance. NICE, Accessed 27 August 2024.
8. Liu, Angus. From market withdrawal back to £3B peak sales: GSK dreams big for myeloma ADC Blenrep. Fierce Pharma, 17 June 2024.
9. Blenrep (belantamab mafodotin) combinations in multiple myeloma application accepted for review by the European Medicines Agency. GSK, 19 July 2024.