Resminostat's approval by the EMA (and the FDA, MHRA and more): How long will you have to wait?

Cutaneous T-cell lymphoma (CTCL) is a rare type of cancer, affecting around 8 in a million people ¹. There's a range of treatments available for the condition, such as topical steroids, phototherapy, systemic chemotherapy, and targeted therapies like vorinostat and romidepsin. Therefore, Kinselby (resminostat) is not the first or only treatment option for CTCL patients. However, treatments for advanced-stage CTCL remain limited.

An EMA approval of resminostat could be especially interesting to European patients as other treatment options like voriostat and romidepsin have faced approval issues and aren't available in the region.

Here's what we know about the timelines of reminostat's potential approval and availability in Europe, the UK, and beyond. 

What is resminostat used for?

Kinselby (resminostat) is a medicine developed for the treatment of cutaneous T-cell lymphoma (CTCL). More specifically, it's intended as a maintenance treatment for patients whose CTCL has progressed after previous systemic treatment ². 

How effective is resminostat in clinical trials?

Kinselby's safety and efficacy in treating cutaneous T-cell lymphoma have been tested in the RESMAIN phase 2 clinical trial. The most important reported results were:

• Resminostat showed a 97.6% improvement in progression-free survival (PFS) vs placebo (median PFS was 8.3 months for resminostat vs 4.2 months for placebo);
• The median time to next treatment was 8.8 months for resminostat patients and 4.2 months for the placebo group;
• Median "total" PFS (from start of last prior therapy to disease progression) was 24.3 months for resminostat patients and 14.9 months for the placebo group ³.

These clinical trial results showed that resminostat can postpone disease progression in advanced CTCL - a significant finding for both patients and doctors. The RESMAIN study has been the basis for submitting marketing approval applications in several countries. 

Is resminostat approved anywhere?

Not as of May 2024. Marketing authorization applications have been submitted and are under review in:

• The USA (with orphan drug designation) ⁴;
• The EU (with orphan designation) ⁵.

Kinselby's manufacturer, 4SC, has announced its intention to also submit marketing authorization applications to the MHRA in the UK and Swissmedic in Switzerland. These are currently in preparation ⁶.

When will Kinselby (resminostat) get EMA approval?

Resminostat's EMA approval application has been officially in review since 29th February 2024. The review process takes up to 210 days, unless additional data is requested from the manufacturer. If we assume the best-case scenario, Kinselby should be getting a positive recommendation from the CHMP by October 2024. From that point on, it takes up to another 67 days for the EMA approval to be final. 

When will resminostat be available in Europe?

Unfortunately, approval is not the same as availability. Even if resminostat gets EMA approval by the end of 2024 or early 2025, it will not be accessible to patients across Europe immediately. 

Each member state takes a different amount of time to negotiate local prices, decide on reimbursement, and launch the newly approved medicine on the market. In Germany, orphan medicines such as resminostat, become available within 102 days on average. However, the EU average of 636 days is much less encouraging. Specific countries like Estonia can even take up to 1,081 days on average to make a new medicine available ⁷.

Therefore, where you are based is a big factor in when resminostat will be available to you. It could be as early as mid-2025, or as late as 2028.

When will Kinselby (resminostat) be approved in the UK?

An official marketing authorization application should be submitted to the MHRA any day now. However, even without one, there are post-Brexit regulations in place allowing the MHRA 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 ⁸.

Whether it goes down this road is for the MHRA to decide, but theoretically, resminostat could be approved in the UK around the same time as in the rest of Europe.

When will resminostat be available in the UK?

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

As of May 2024, NICE has not initiated an evaluation or resminostat, meaning that it's impossible to say when a potential decision will come. Assuming the best-case scenario, where the MHRA follows a potential EMA approval in late 2024, and NICE makes a positive decision soon after, resminostat could be available in the UK by mid-2025. However, only time will tell if this is how the process goes. 

How to get resminostat before its FDA, EMA or MHRA approval

Despite what the timelines above suggest, waiting is not the only option for CTCL patients in the USA, Europe, the UK, or elsewhere.

As soon as resminostat 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.

Resminostat 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 Kinselby (resminostat) 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 resminostat as soon as it's approved somewhere in the world.

References:

1. Linos, E. Incidence Trends of Primary Cutaneous T-Cell Lymphoma in the US From 2000 to 2018: A SEER Population Data Analysis. NCBI, 1 September 2022.
2. RESMAIN Study Results to be Presented at the EORTC Cutaneous Lymphoma Tumour Group Annual Meeting 23 September 2023. 4SC, 23 September 2023.
3. Stadler, R.; Scarisbrick, J. Landmark RESMAIN study data presented at the EORTC Cutaneous Lymphoma Tumour Group Annual Meeting - 4SC AG. 4SC, 25 September 2023.
4. 4SC receives Orphan Drug Designation (ODD) for resminostat (Kinselby) in CTCL from the US FDA. 4SC, Accessed 28 May 2024.
5. 4SC Files Marketing Authorisation Application with EMA for Resminostat (Kinselby). 4SC, 1 March 2024.
6. 4SC AG: Paediatric Investigation Plan waiver for resminostat from the UK MHRA received. 4SC, 15 April 2024.
7. EFPIA Patients W.A.I.T. Indicator 2021 Survey. EFPIA, Accessed 28 May 2024.
8. Fast-Tracking Approval of Medicines - UK Publishes Detailed Guidance on its New International Recognition Procedure. Inside EU Life Sciences, 11 September 2023.