The US FDA approves lenalidomide as post-ASCT maintenance therapy for MM

Lenalidomide is a prescription immunomodulatory drug that was approved in 2006 for use in combination with dexamethasone to treat patients with Multiple Myeloma (MM) who have had prior therapy. It is also approved to treat select patients with certain types of myelodysplastic syndromes. In 2015 the use of lenalidomide was expanded to include the treatment, in combination with dexamethasone, of patients with newly diagnosed MM who are not eligible for autologous stem cell transplant (ASCT).

On February 22, 2017, the U.S. Food and Drug Administration approved lenalidomide as maintenance therapy for patients with MM following autologous stem cell transplant. This approval was based on two randomized, controlled trials:

Key Information 

• Two key trials were considered - CALGB 100104 and IFM 2005-02, in which the efficacy of lenalidomide as a maintenance therapy for the treatment of MM in patients after autologous stem cell transplant was evaluated
• In the primary analysis, approximately a 15-month (CALGB) and 18-month (IFM) progression-free survival advantage was observed in patients treated with lenalidomide, compared to those receiving a placebo (hazard ratio (HR) in CALGB=0.38; 95% CI: 0.27, 0.54; p<0.001 and HR in IFM=0.50; 95% CI: 0.39, 0.64; p<0.001)
• Results of the CALGB and IFM trials, respectively:
  • Median OS = 111 and 106 - lenalidomide treated group
  • Median OS = 84 and 88 months - placebo group
• AEs across the two trials were similar to those outlined in the product label
• Neutropenia was the most commonly reported grade 3/4 AE and affected 56% of the 517 patients treated with lenalidomide in both trials
• As already noted in the product label, an increased incidence of second primary malignancies was reported among patients treated with lenalidomide compared with those receiving placebo
• Recommended dosing schedule is 10mg once daily continuously on days 1-28 of repeated 28-day cycles