Lenalidomide is an immunomodulatory drug and a structural analogue of thalidomide which has been developed by Celgene. Potential clinical applications investigated for lenalidomide include CNS cancer, inflammation, malignant melanoma, chronic lymphocytic leukaemia, myelodysplastic syndromes, and multiple myeloma (MM). REVLIMID® (lenalidomide) in combination with dexamethasone is indicated for the treatment of multiple myeloma patients who have received at least one prior therapy.
The consensus that Revlimid is appropriate for first line therapy is reflected in a Phase III ECOG trial that investigated high versus low dose dexamethasone with Revlinid in first line therapy. On 4/5, Celgene Corporation (Nasdaq: CELG) announced that the Eastern Cooperative Oncology Group (ECOG) has reported that its Data Monitoring Committee’s (DMC) review of preliminary results from a large, randomized clinical trial for patients with newly diagnosed multiple myeloma has found that the use of a low dose of dexamethasone (Decadron) in combination with lenalidomide suggests survival advantage for patients when compared to the higher, standard-dose of dexamethasone that is used in combination with lenalidomide to treat. NCCN lists it as 2B recommendation of p. 17 of NCCN guidelines for myeloma. On this basis, it can be considered to be medically necessary.
Palumbo A, Falco P, Gay F, et al. Bortezomib-doxorubicin-dexamethasone as induction prior to reduced intensity autologous transplantation followed by lenalidomide as consolidation/maintenance in elderly patients. Blood. 2008;112:66, abstract number 159.
Matthew Strobeck From the analyst’s couch: Multiple myeloma therapies Nature Reviews Drug Discovery 6, 181-182 (March 2007)
Weber D, Chen C, Niesvizky R, et al. Lenalidomide Plus High-Dose Dexamethasone Provides Improved Overall Survival Compared to High-Dose Dexamethasone Alone for Relapsed or Refractory Multiple Myeloma (MM): Results of a North American Phase III Study (MM-009). Proceedings from the 42nd annual meeting of the American Society of Clinical Oncology. Atlanta, Ga. June 2006. Abstract # 7521.