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NICE approves lenalidomide in front-line multiple myeloma treatment 

May 21, 2019

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


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 trial 4
    • Continuous len + dex (Rd, n = 535) versusmelphalan + prednisone + thalidomide (MPT, n = 547)
    • Significant increase in PFS with Rd vsMPT: 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

  1. Lenalidomide plus dexamethasone for previously untreated multiple myeloma: Final appraisal document[accessed 2019 May 20]
  2. Four years after EU approval, NICE finally backs Revlimid use in certain first-line multiple myeloma patients [accessed 2019 May 17]
  3. European Medicines Agency: Summary of opinion (post-autorisation): Revlimid (lenalidomide) February 2015.[accessed 2019 May 21]
  4. Facon T. et al.Final analysis of survival outcomes in the phase 3 FIRST trial of up-front treatment for multiple myeloma. Blood. 18 January 2018. DOI: 10.1182/blood-2017-07-795047