The China Food and Drug Administration (CFDA) has approved lenalidomide (Revlimid®) to treat patients with newly diagnosed multiple myeloma (MM).
The drug is now approved for use in combination with dexamethasone to treat adults with previously untreated MM who are not eligible for transplant.
Lenalidomide was first approved by the CFDA in 2013 for use in combination with dexamethasone to treat adults with MM who had received at least one prior therapy.
“In China, where the incidence of multiple myeloma is on the rise due to an aging population and improved diagnosis, we are hopeful that newly diagnosed patients will have a meaningful long-term benefit from this approval,” said John V. Oyler, founder, chief executive officer, and chairman of BeiGene, the company marketing lenalidomide as Revlimid in China under an exclusive license from Celgene Corporation.
The CFDA’s decision to expand the approval of lenalidomide is based on results from the phase 3 FIRST trial. Updated results from this study were published in the Journal of Clinical Oncology in November 2016.
The trial included 1623 patients with newly diagnosed MM who were not eligible for stem cell transplant.
Patients were randomized to receive:
- Lenalidomide and low-dose dexamethasone (Rd) in 28-day cycles until disease progression (n=535), known as the “continuous Rd group”
- 18 cycles of Rd (Rd18) for 72 weeks (n=541), known as the “Rd18 group”
- Melphalan, prednisone, and thalidomide (MPT) for 72 weeks (n=547).
In the intent-to-treat population, the overall response rate was 81% for the continuous Rd group, 79% for the Rd18 group, and 67% in the MPT group. The complete response rates were 21%, 20%, and 12%, respectively.
The median progression-free survival was 26.0 months in the continuous Rd group, 21.0 months in the Rd18 group, and 21.9 months in the MPT group. At 4 years, progression-free survival rates were 33%, 14%, and 13%, respectively.
The median overall survival was 58.9 months in the continuous Rd group, 56.7 months in the Rd18 group, and 48.5 months in the MPT group. At 4 years, overall survival rates were 60%, 57%, and 51%, respectively.
The most frequent grade 3/4 hematologic treatment-emergent adverse events were neutropenia and anemia. The rate of grade 3/4 neutropenia was higher in the MPT group than the continuous Rd or Rd18 groups.
Infections were the most common grade 3/4 non-hematologic treatment-emergent adverse events. The rate of grade 3/4 infections was higher in the Rd groups than the MPT group.