Revlimid Gains FDA Approval for NDMM Patients

Celgene announced on Feb. 18, 2015 that its cancer drug Revlimid (lenalidomide) was approved by FDA in combination with dexamethasone to treat patients with newly diagnosed multiple myeloma (NDMM). In 2006, Revlimid, in combination with dexamethasone, was approved for use in multiple myeloma patients who had previously received at least one treatment. This announcement comes four days before its previously anticipated approval date.

According to Reuters, US doctors have prescribed Revlimid in new patients on an off-label basis, however, lacking regulatory approvals, Celgene was unable to market the product for this indication. The approval is expected to go through with European regulators in the next few weeks, opening up the market for European physicians who were previously unable to prescribe Revlimid to NDMM patients due to off-label regulations in Europe. Fifty percent of multiple myeloma patients of approximately 93,600 patients living with the disease in Europe and 88,499 in the US are newly diagnosed.

"The approval of Revlimid as an option for use in all patients with multiple myeloma represents a new paradigm in the management of this disease. We now have clinical evidence demonstrating that starting and keeping newly diagnosed multiple myeloma patients on Revlimid significantly improves progression-free survival,” said Kenneth Anderson, MD, director, Jerome Lipper Multiple Myeloma Center, Dana-Farber/Brigham and Women's Cancer Center, in a press release.

Lenalidomide is currently in Phase I/II for the treatment of relapse/refractory Waldenström macroglobulinemia, which is a type of non-Hodgkin lymphoma wherein the cancer cells make large amounts of an abnormal protein called macroglobulin, according to the American Cancer Society.

Source: Celgene