FDA approves Celgene's Revlimid in combination with dexamethasone to treat multiple myeloma

PBR Staff Writer Published 19 February 2015

The US Food and Drug Administration (FDA) has expanded the existing indication for Celgene's Revlimid (lenalidomide) in combination with dexamethasone to include patients newly diagnosed with multiple myeloma (NDMM).

In June 2006, Revlimid plus dexamethasone was approved for use in multiple myeloma patients who have received at least one prior therapy.

The approval of Revlimid was based on safety and efficacy data from Phase III trials, including the FIRST trial (MM-020/IFM 07-01),

The randomized, open-label, three-arm FIRST trial evaluated continuous Revlimid in combination with dexamethasone (Rd Continuous) until disease progression versus melphalan, prednisone and thalidomide (MPT) for 18 months as the primary analysis, and a fixed duration of 18 cycles of Rd (Rd18) as a secondary analysis, in 1,623 newly diagnosed patients who were not candidates for stem cell transplant.

Median progression-free survival (PFS), which is the length of time a patient lives from study randomization to disease progression or death, was the primary endpoint of the study.

Currently, the company has an application under review with the European Medicines Agency (EMA) for approval to use Revlimid to treat adult patients with previously untreated multiple myeloma who are not eligible for transplant.

In the US, Revlimid is approved in combination with dexamethasone to treat multiple myeloma.

Currently, Revlimid is approved in the US, Canada, Switzerland, Australia, New Zealand and several Latin American countries, as well as Malaysia and Israel, for transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities.

In Europe, Revlimid is approved to treat patients with transfusion-dependent anemia due to low- or intermediate-1-risk MDS associated with an isolated deletion 5q cytogenetic abnormality when other therapeutic options are insufficient or inadequate.

More:
FDA approves Celgene's Revlimid in combination with dexamethasone to treat multiple myeloma