Revlimid results look promising for multiple myeloma patients

Mar 8 2005

The Multiple Myeloma Research Foundation (MMRF) applauded today's Celgene announcement regarding Revlimid, a new class of novel immunomodulatory drugs currently being evaluated to treat a broad range of hematology and oncology conditions, including multiple myeloma.

"Today's Revlimid announcement provides a new and important option for patients to assist in their fight against multiple myeloma," said Kathy Giusti, president and founder of the MMRF and a multiple myeloma patient. "It has been a privilege to partner with Celgene on Revlimid and we're thankful for their continued commitment and impressive results. We're of course also extremely appreciative of the clinicians and patients who made this all possible."

Celgene announced today that the Independent Data Monitoring Committee determined that two Phase III Special Protocol Assessment pivotal trials overwhelmingly exceeded the pre-established efficacy stopping rule of p <0.0015 for the primary endpoint, time to disease progression. Further, Celgene will now unblind the studies and allow all patients in both studies access to Revlimid. Celgene also indicated that plans are being formulated to create expanded access programs for patients with previously treated myeloma.

In addition to providing research funding to support Revlimid, the MMRF has worked closely with Celgene and the centers that moved the study forward to assist their efforts to expedite the Revlimid trial, with thousands of individuals directed to the trials via the MMRF's Clinical Trials Monitor (CTM) program.

Revlimid is a member of a new class of novel immunomodulatory drugs, or IMiDs(R). Celgene is evaluating treatments with Revlimid for a broad range of hematology and oncology conditions, including: multiple myeloma, the malignant blood cell disorders known as myelodysplastic syndromes (MDS) as well as solid tumor cancers. Revlimid affects multiple intracellular biological pathways. The IMiD pipeline, including Revlimid, is covered by a comprehensive intellectual property estate of U.S. and foreign issued patents and pending patent applications including composition-of-matter and use patents.

Revlimid (lenalidomide) is not approved by the FDA or any other regulatory agencies as a treatment in any indication and is currently being evaluated in clinical trials for efficacy and safety for future regulatory applications.