CHMP recommends Revlimid for treatment of Multiple Myeloma ineligible for stem cell transplantation- Celgene
Celgene International Sàrl, announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for continuous oral treatment with Revlimid in adult patients with previously untreated Multiple Myeloma who are not eligible for stem cell transplantation.
The CHMP reviews applications for all 28 member states in the European Union (EU), as well as Norway , Liechtenstein and Iceland . The European Commission , which generally follows the recommendation of the CHMP, is expected to make its final decision in approximately two months.
The CHMP recommendation in newly diagnosed multiple myeloma was based on the results of two pivotal studies: MM-015 and MM-020 (also known as FIRST). The results of these studies have been reported previously.