NICE approves lenalidomide in front-line multiple myeloma treatment 

The National Institute for Health and Care Excellence in the United Kingdom (UK) has backed the use of lenalidomide in patients with previously untreated multiple myeloma (MM) who are not eligible for transplant.^1,2 The decision comes four years after the European Medicines Agency (EMA) approved lenalidomide in the same indication.^2,3

Background

Currently, thalidomide-based therapy is the standard of care for NDMM. In patients for whom thalidomide is contraindicated or not tolerated, bortezomib-based therapies are used. Bortezomib-based therapies, in combination with an alkylating agent and corticosteroid, may cause side effects and reduce the number of options available to the patient later in the treatment pathway.¹

The evidence to support the decision comes from:

• FIRST trial; an open label, randomized trial⁴
  • Continuous len + dex (Rd, n = 535) versus melphalan + prednisone + thalidomide (MPT, n = 547)
  • Significant increase in PFS with Rd vs MPT: HR = 0.69 (95%CI, 0.59-0.79); P < 0.00001
  • Patients who were treated with bortezomib-based therapy after Rd, displayed better-quality responses to second-line treatment than those who received bortezomib-based therapy after MPT
  • The results of this trial supported the use of Rd as upfront therapy in MM
• An indirect comparison between len + dex and bortezomib + melphalan + prednisone (VMP)¹
  • Overall survival was improved in the len + dex arm compared to VMP arm (hazard ratio: 0.70, 95% CI, 0.5-0.98), as was PFS (hazard ratio: 0.74, 95% CI, 0.52-1.05)

This means that lenalidomide (len) will now be available in combination with dexamethasone (dex) for the treatment of patients who are not eligible for transplant, who are treatment naïve (newly diagnosed MM [NDMM]) and for whom thalidomide is contraindicated or not tolerated. The estimated number of patients expected to benefit is 2,100.²