Bristol-Myers Squibb Co.'s Revlimid in combination with Roche Holding AG's Rituxan has been approved by the European Commission to treat the blood cancer follicular lymphoma.
Revlimid, or lenalidomide, in combination with rituximab is now approved in the EU to treat patients with follicular lymphoma who are either not responding to the current therapy or their cancer has returned following previous treatment, Bristol-Myers Squibb said in a Dec. 20 press release.
Follicular lymphoma is a type of cancer that develops when the body makes abnormal versions of a type of white blood cell called B lymphocytes, or B cells, which help protect the body against bacteria or viruses by making proteins called antibodies.
The approval is based on a phase 3 study called Augment , which showed that the drug combination significantly improved progression-free survival in patients with follicular lymphoma. Progression-free survival refers to the length of time a patient lives without the disease worsening and is a measure of how well a therapy works.
The Revlimid combo was backed by the EMA's Committee for Medicinal Products for Human Use. The U.S. Food and Drug Administration has approved the Revlimid-Rituxan combination to treat patients with follicular lymphoma.
Bristol-Myers acquired Revlimid through the $95 billion acquisition of Celgene Corp., which closed in late November.