Pfizer Ltd announced today that the National Institute for Health and Care Excellence (NICE) has issued final draft guidance recommending Elrexfio® (elranatamab) for use on the NHS in England via the Cancer Drugs Fund (CDF). The treatment is recommended with managed access as an option for treating relapsed and refractory multiple myeloma in adults, only after three or more lines of treatment (including an immunomodulatory drug, a proteasome inhibitor and an anti-CD38 antibody) when the multiple myeloma has progressed on the last treatment.
The updated NICE guidance comes shortly after the Scottish Medicines Consortium (SMC) accepted elranatamab for use within NHS Scotland on an interim basis on 9th September 2024, subject to ongoing evaluation and future reassessment. It also supersedes previous draft NICE guidance, published in July, in which elranatamab was only recommended if pomalidomide plus dexamethasone would otherwise be offered.
Dr Ruhe Chowdhury, Oncology Medical Director, Pfizer UK, said: “We are pleased that NICE has reviewed its earlier position and taken the decision to recommend elranatamab without the pomalidomide plus dexamethasone restriction, meaning that more patients will now be able to access the treatment via the NHS rather than just a select few.
“This is important considering the relapsing and remitting nature of the disease and the fact that patients continue to need additional options, especially as their cancer advances and stops responding to earlier lines of therapy.”
Caroline Donoghue, Senior Policy Officer at blood cancer charity Myeloma UK, said: ”This is brilliant news. Elranatamab is part of a brand-new class of drugs in the UK and will have a huge impact on patients and their families. In fact, we know that it has already changed the lives of many people who were close to running out of treatment options.
“As soon as we heard about the restriction on access to elranatamab we challenged the decision. We believed it was deeply unfair to keep this drug out of reach from those who needed it most. We worked with clinicians and made sure that patients were heard and that their needs were put front and centre. Until we have a cure, it is absolutely vital that all myeloma patients are given as many options to tackle their cancer as possible – no matter where they are on their treatment journey.”
Myeloma is a type of cancer that develops from plasma cells in the bone marrow. According to the latest UK figures (2017-2019), around 6,000 new cases of myeloma are diagnosed and more than 3,000 people die from the disease. Although treatment can often help to control the condition and improve quality of life, it cannot currently be cured. About 55 per cent of people with myeloma in England will survive for five years or more after diagnosis.
People with myeloma often experience symptoms and complications, such as pain, persistent fatigue and recurring infections, which can have a considerable impact on their everyday activities. Having access to new targeted treatments can help relieve symptoms and enable patients to live better with their cancer, particularly at the later stages of the disease.
Elranatamab is a B-cell maturation antigen (BCMA)-directed bispecific antibody (BsAb). It works by binding to the BCMA, which is found on myeloma cells, and signalling for immune cells to destroy the cancerous cells. This class of medicine is distinct from other available myeloma treatments and offers a new mechanism of action.
Clinical evidence for the NICE recommendation came from MagnetisMM-3, an open-label, non-randomised, multicentre, Phase 2 study. After more than two years of follow-up, the objective response rate (partial response or complete response) for patients on elranatamab was 61 per cent (n=75). Patients also demonstrated a median overall survival of 24.6 months (CI 95 per cent), with median progression-free survival of 17.2 months (CI 95 per cent).
