Multiple myeloma has long been considered as a cancer that usually forms in a type of white blood cell called a plasma cell, which, in turn, is responsible in fighting off infections by making antibodies that recognize and attack germs. That said, the American biotechnology company Celgene has recently announced the FDA's approval of an expanded indication of their drug, lenalidomide or also referred to as Revlimid. The company executives said that the approval will serve as a maintenance therapy for patients with multiple myeloma following autologous hematopoietic stem cell transplant or auto-HSCT.
Lenalidomide: Celgene's Multiple Myeloma Drug
According to reports revealed by Medscape, being the first and the only drug with such an indication, the approval was said to have been based on data from two controlled studies known as United States-based CALGB 100104 trial and the European-based IFM 2005-02 trial. It was found that the study's trials have included more than 1000 patients who had undergone an auto-HSCT after induction therapy. Additionally, the study findings show that as compared with no maintenance therapy, lenalidomide maintenance therapy has improved median progression-free survival (PFS), which is mainly the study's endpoint, and thus, making researchers successful in their goals.
Furthermore, in one of his statements reported by OncLive, Philip McCarthy, a director at Blood and Marrow Transplant Center, Department of Medicine at Roswell Park Cancer Institute, said that such autologous stem cell transplant, particularly after the induction therapy, is basically a part of the standard continuum of care for transplant-eligible multiple myeloma patients. However, he highlighted the fact that most patients will still see their disease recur or progress after this treatment. McCarthy adds that Lenalidomide maintenance therapy, which has been shown to increase progression-free survival following autologous stem cell transplant in clinical trials can be considered a standard of care for these patients.
Meanwhile, despite the fact that a survival advantage for lenalidomide as maintenance therapy has not been demonstrated consistently, experts have highly emphasized that in this analysis, there is a clear evidence that lenalidomide prolongs the overall survival of the patient. Moreover, lenalidomide's prescribing information notes that patients with myeloma treated with lenalidomide may develop deep-vein thrombosis, pulmonary embolism, myocardial infarction, and stroke, hence, experts recommend thromboprophylaxis as a prevention method.