Next-generation drug turned down in Scotland
Belantamab mafodotin (Blenrep®) has been turned down by the Scottish Medicines Consortium (SMC).
A next-generation treatment which could have given patients at fifth line and beyond remissions of over a year has been turned down by the Scottish Medicines Consortium (SMC).
Belantamab mafodotin (Blenrep®) would have been the first drug of its kind for patients who have received at least four rounds of treatment.
But the SMC’s appraisal committee argued there was insufficient data on how well belantamab mafodotin works compared to existing treatments.
This comes four months after the drug was also rejected by the National Institute for Health and Care Excellence (NICE) for use on the NHS in England and Wales.
However, belantamab mafodotin will remain available to patients already on the treatment through drug manufacturer GSK’s compassionate use scheme.
It will also continue to be available in combination with other drugs in some clinical trials.
Shelagh McKinlay, Director of Research and Advocacy at Myeloma UK said:
“This is extremely disappointing and will come as a blow for patients who have already had multiple lines of treatment. While this is without a doubt a setback, there are many promising treatments in the pipeline, and we will be there every step of the way to make sure these are approved and get to the patients who need them most as soon as possible.
“It’s becoming clearer that the drug approval system needs to change to deliver for people with myeloma. It is sadly often difficult to get approval for drugs for small groups of patients because of the challenge of gathering enough evidence. This has to change. We need better data and more flexibility to make sure that patients receive the most effective drugs.
“We won’t rest until the system delivers for all those it’s meant to serve: patients.”
Based on the latest data from the DREAMM-2 clinical trial, 32% of patients (31 of 97) responded to belantamab mafodotin and had an average remission of 12 and a half months.
As an antibody-drug conjugate, belantamab mafodotin specifically targets a protein on the surface of myeloma cells called BCMA. This helps deliver chemotherapy straight to the myeloma cells and flags them for the patients’ immune system to kill.
But other treatments for patients at fourth line and beyond will be making their way through the appraisal process over the coming months and Myeloma UK will submit evidence for each of them.
These include selinexor (Nexpovio®) in combination with dexamethasone for patients who have received at least four prior lines of treatment, and isatuximab (Sarclisa®) in combination with pomalidomide (Imnovid®) and dexamethasone for fourth-line patients.
Dr Christopher McDermott, Consultant Haematologist at The Beatson West of Scotland Cancer Centre, said:
“The rejection of belantamab by the SMC is disappointing. However, ongoing clinical trials are assessing new drugs and new combinations of existing drugs, aiming to get the best response possible for patients. In particular, trials for bispecific antibodies show promising results and offer an exciting new line of treatment in selected patients.”
What about patients in Northern Ireland?
As of the end of February 2024, new patients in Northern Ireland will no longer be able to access belantamab mafodotin through compassionate use schemes. However, the drug will remain available in combination with others in some clinical trials.
Current patients will continue to receive treatment as agreed with their clinician.
Other treatments for patients at fourth line and beyond will be making their way through the appraisal process over the coming months.
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