Pioneering treatment set to give patients at fifth line and beyond more time

A treatment that could give patients at fifth line and beyond more time with their loved ones has been approved on the NHS in England and Wales. 

A new way to target myeloma, SD combines selinexor (Nexpovio®) and dexamethasone, and is an innovative option for patients at this point in the pathway.

It is aimed at people who have received at least four treatments and whose myeloma has become resistant to a minimum of two proteasome inhibitors – eg bortezomib, carfilzomib and ixazomib – as well as two immunomodulatory agents such as lenalidomide, thalidomide or pomalidomide and an anti-CD38 monoclonal antibody like daratumumab or isatuximab. 

Around 350 people each year could now benefit from SD.

Based on the latest data from the STORM clinical trial, over a quarter of patients responded well to SD. The average survival was nearly eight and a half months. 

With selinexor now available to patients at both second and fifth line, it is hoped the National Institute for Health and Care Excellence (NICE) will also approve the drug for use at third line over the coming weeks. 

Shelagh McKinlay, Director of Research and Advocacy at Myeloma UK, said:

“This is such welcome news. This treatment will make a difference to patients who have exhausted nearly all other avenues and were potentially facing the prospect of end-of-life care. 

“We know that, over time, myeloma can become resistant to treatments so, until we have a cure, it is vital that all patients are given as many new options as possible to tackle their cancer. 

“It is particularly good news that this treatment is available to patients who have had four or more treatments – not limited to a single line of treatment. This wider access is something we always press for.

“While we’re delighted with the decision, our work is far from over. Now that NICE has recognised the clear benefits of selinexor for patients further down the treatment pathway, we’re more determined than ever to ensure it is approved in combination with bortezomib and dexamethasone (SVD) at third line as soon as possible. 

“Everyone affected by myeloma deserves to live a full life no matter where they are on their treatment journey.”  

Selinexor is a new type of drug known as a selective inhibitor of nuclear export (SINE). It tackles myeloma in a completely different way to currently approved drugs and provides an alternative for patients who have relapsed multiple times or do not respond to available treatments. 

Selinexor stops a protein called Exportin 1 (XPO1) from working properly.  

XPO1 is responsible for moving other proteins between different parts of the cell. Myeloma cells exploit XPO1 to get rid of proteins, called tumour suppressor proteins, which would stop them growing and multiplying.  

By blocking XPO1, the tumour suppressor proteins build up within the myeloma cells, killing them. 

What does this decision mean for patients?

This approval means that myeloma patients at fourth relapse (fifth line) whose myeloma is resistant to at least two proteasome inhibitors (bortezomib, carfilzomib or ixazomib), two immunomodulatory drugs (thalidomide, lenalidomide or pomalidomide) and an anti-CD38 monoclonal antibody (daratumumab or isatuximab) can now receive selinexor in combination with dexamethasone.

It gives patients whose myeloma is resistant to multiple treatments access to a treatment which kills the myeloma cells in a new way. 

What are the benefits of selinexor (Nexpovio®) and dexamethasone for people at fifth line and beyond?

According to the latest data from the STORM clinical trial, over a quarter of patients x responded well to SD and had an average remission of nearly three months.

Patients’ average survival was nearly eight and a half months.

What about patients in Scotland and Northern Ireland?

In Scotland, the Scottish Medicines Consortium decides which treatments are funded by the NHS. The SMC appraisal of SD will hopefully take place this year.

In Northern Ireland, the Department for Health decides which treatments are funded by the NHS. It usually follows the guidance issued by NICE.

When will selinexor (Nexpovio®) and dexamethasone be available on the NHS?

 A treatment should be made available to patients through the NHS within 90 days of the publication of NICE’s final decision.

The final decision is published 15 working days after the public has been notified of the decision following the standard notice period for any appeal requests.

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