Bristol Myers Squibb’s (BMS) Revlimid (lenalidomide) has received a recommendation from the UK’s National Institute of Health and Care Excellence (NICE) for newly diagnosed multiple myeloma patients.

In its Final Appraisal Document (FAD), NICE recommended Revlimid as a maintenance treatment after autologous stem cell transplant (ASCT) for newly diagnosed multiple myeloma in adults.

In September 2020, NICE initially turned down NHS funding of Revlimid in this indication, after concluding that the cost-effectiveness estimates for the drug in this setting were uncertain.

According to BMS, around 1,150 eligible patients in England will have immediate access to Revlimid from today, with interim funding provided via the Cancer Drugs Fund (CDF).

The recommendation is supported by data from two Phase III studies, in which Revlimid maintenance treatment significantly improved progression-free survival (PFS) in newly diagnosed multiple myeloma patients after ASCT compared with placebo.

This includes the CALGB 100104 study, where median PFS for patients receiving Revlimid was 57.3 months compared to 28.9 months in the placebo group.

In the IFM 2005-02 study, median PFS was 41 months for patients receiving Revlimid compared to 23 months in the placebo group.

“We are delighted with this outcome. Patients who receive Revlimid maintenance after high-dose therapy and stem cell transplant have a significant increase in overall survival, so the decision to make this available through the NHS is fantastic news,” said Laura Kerby, chief executive of Myeloma UK.

In the UK, around 1,500 newly diagnosed multiple myeloma patients undergo ASCT each year, although most will eventually relapse.

This first remission period is critical for people living with multiple myeloma, as it can be an indicator of the overall survival of the disease.

It has been shown that effective maintenance therapy at this stage of the disease could be ‘essential’ for long-term survival.