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revlimidDecember 10 2015

Patients in Scotland with previously untreated multiple myeloma who are not eligible for stem cell transplant and who are unsuitable for thalidomide-containing regimens will now have access to lenalidomide, a treatment that when combined with low-dose dexamethasone has been shown in phase III trials to significantly improve progression-free survival (PFS) and overall survival (OS) rates when compared with melphalan-prednisone-thalidomide (MPT), the current standard of care.

The Scottish Medicines Consortium (SMC) has announced that REVLIMID® (lenalidomide) has been accepted for use within NHS Scotland, in combination with dexamethasone for the treatment of adults with previously untreated multiple myeloma, who are not eligible for stem cell transplant and who are unsuitable for thalidomide-containing regimens.

Multiple myeloma is a persistent, relapsing and remitting, life-threatening blood cancer that is characterised by tumour proliferation and immune system dysfunction. It is the second most common type of blood cance and approximately 380 new cases of multiple myeloma are diagnosed in Scotland each year. The median age of multiple myeloma diagnosis is 65-70 years of age. Intensive treatment involving stem cell transplantation is not usually considered in patients over 65, as it is associated with a risk of adverse events and complications, which can prove problematic in older patients or those with other underlying medical conditions.

"Today's advice from the SMC is good news for myeloma patients in Scotland," said Dr Iain Singer, Consultant Haematologist at Monklands Hospital, NHS Lanarkshire. "We know that lenalidomide is an effective treatment for multiple myeloma and have a lot of experience of using this drug. It's really positive that we can now use it to treat select newly-diagnosed patients where the clinical trials have shown real patient benefit."

The FIRST trial, MM-020, published last year in the New England Journal of Medicine,[1] demonstrated that PFS was significantly improved in patients treated continuously with lenalidomide plus dexamethasone (Rd), compared with those receiving melphalan-prednisone-thalidomide (MPT) (the median PFS at the data cut-off on 3 March 2014 was 26.0 months with Rd vs. 21.0 months with MPT). Median OS in patients receiving Rd continuous therapy was 58.9 months, vs. 48.5 months for patients treated with MPT (HR 0.75; 95% CI 0.62, 0.90), based on a 3 March 2014 interim OS analysis. The numbers of patients experiencing any grade 3 or 4 adverse events were similar in each group.

Commenting on the news, Eric Low, Chief Executive of Myeloma UK, which is headquartered in Edinburgh, said:

"This is great news for myeloma patients in Scotland. I commend the efforts of the SMC and Celgene for working together to ensure the availability of lenalidomide for newly diagnosed myeloma patients in Scotland. We will now focus our efforts on ensuring lenalidomide is approved in the other parts of the UK; it is imperative that there is fair and equal access to effective treatments across the whole of the UK, irrespective of where you live."

About lenalidomide

In the European Union, lenalidomide is approved in combination with dexamethasone for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for transplant. Lenadlidomide is also approved in combination with dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy in nearly 70 countries.

Lenalidomide is also approved in Europe for the treatment of patients with transfusion-dependent anaemia due to low- or intermediate-1-risk myelodysplastic syndromes associated with an isolated deletion 5q cytogenetic abnormality when other therapeutic options are insufficient or inadequate.

About Celgene Limited

Celgene Limited, located in Uxbridge, United Kingdom, is a wholly owned subsidiary of Celgene Corporation.  Celgene Corporation, headquartered in Summit, New Jersey, is an integrated global pharmaceutical company engaged primarily in the discovery, development and commercialisation of innovative therapies for the treatment of cancer and inflammatory diseases through gene and protein regulation.

Links:

Celgene

Medicines Database

Scottish Medicines Consortium

Myeloma: an Introduction

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