Celgene's Revlimid --lenalidomide-- Exceeds Expectations in Relapsed and Refractory Myeloma.NORTH HOLLYWOOD, Calif. -- Early this morning, Celgene Corporation reported that the company's investigational drug Revlimid(R), also known as lenalidomide (and previously as CC-5013) has shown outstanding results in the treatment of relapsed or refractory myeloma myeloma /my·elo·ma/ (mi?e-lo´mah) a tumor composed of cells of the type normally found in the bone marrow. giant cell myeloma see under tumor (1). in two Phase III clinical trials. The Independent Data Monitoring Committee (IDMC IDMC Internal Displacement Monitoring Centre IDMC Independent Data Monitoring Committee IDMC International Display Manufacturing Conference IDMC Illinois Dull Men's Club ) responsible for overseeing these two trials found a statistically significant improvement in time to disease progression -- the primary endpoint of these Phase III trials -- in patients receiving Revlimid plus dexamethasone dexamethasone /dex·a·meth·a·sone/ (dek?sah-meth´ah-son) a synthetic glucocorticoid used primarily as an antiinflammatory in various conditions, including collagen diseases and allergic states; it is the basis of a screening test in the compared to patients receiving dexamethasone alone. The trials have been unblinded many months earlier than originally projected. "This is enormously exciting news for myeloma patients, and it may be exciting news for many other cancer patients too," said Susie Novis, president of the International Myeloma Foundation. "Although we don't know Don't know (DK, DKed) "Don't know the trade." A Street expression used whenever one party lacks knowledge of a trade or receives conflicting instructions from the other party. the detailed results of these trials yet, we do know that: --The trials overwhelmingly showed a delay in time to disease progression for patients receiving Revlimid compared to original projections. --The preliminary safety profile was favorable. --Celgene is allowing all patients in these studies to get Revlimid if they want to. --Plans are under way to offer expanded access to Revlimid for patients with previously treated myeloma (subject to appropriate regulatory approval). --There are trials of Revlimid being carried out in several other types of cancer." "The IMF IMF See: International Monetary Fund IMF See International Monetary Fund (IMF). sincerely hopes that this drug can show similar levels of effectiveness in some other cancers where new treatments are so badly needed," Susie concluded. Revlimid is not approved for clinical use in the US or anywhere else in the world. However, it previously demonstrated activity in the treatment of a subset of patients with myelodysplastic syndrome (MDS MDS, n See temporomandibular pain-dysfunction syndrome. MDS 1 Maternal deprivation syndrome, see there 2 Myelodysplastic syndrome, see there ), a pre-leukemic blood disorder. Celgene is already in process of submitting an NDA (Non Disclosure Agreement) An agreement signed between two parties that have to disclose confidential information to each other in order to do business. In general, the NDA states why the information is being divulged and stipulates that it cannot be used for any for Revlimid based on these MDS data. Celgene has now started talks with the FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. and with international regulatory authorities about potential approval of Revlimid for myeloma too. According to Jerome Zeldis, MD, PhD, "Following preliminary analysis we plan to use this data as the basis of a regulatory submission to the FDA and EMEA (Europe, Middle East, Africa) Refers to that region of the world. For example, one might see products packaged differently for the UK, EMEA and Asia Pacific markets. for Revlimid in previously treated multiple myeloma patients." Dr. Zeldis is Chief Medical Officer and VP, Medical Affairs at Celgene. The Revlimid Phase III trials included patients with relapsed or refractory multiple myeloma. Patients were randomized ran·dom·ize tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es To make random in arrangement, especially in order to control the variables in an experiment. to receive Revlimid plus dexamethasone or dexamethasone alone. The trials enrolled 705 patients and were being conducted at 97 sites around the world. The trial design included a primary endpoint of time to disease progression calculated as the time from randomization randomization (ranˈ·d  ·m to the first documentation of progressive disease based on Blade myeloma response criteria. Dr. Brian Durie, Chairman of the Board of the International Myeloma Foundation, stated, "This announcement makes Revlimid the third new pharmaceutical agent, along with Thalomid and Velcade, to offer hope of extended survival for myeloma patients since late 1999. With progress coming at this pace, there is an increased probability that many myeloma patients and their families can look forward with optimism for even better treatments yet to come." About the IMF The International Myeloma Foundation (IMF) is the country's oldest and largest nonprofit organization dedicated solely to multiple myeloma patients and their caregivers. The IMF offers a broad range of programs and services to aid in the research, diagnosis, treatment, and management of myeloma. The IMF provides support and educational services to more than 110,000 myeloma patients in 113 countries. The IMF offers easy access to medical information and emotional support through its toll-free Hotline, free informational printed materials, educational patient and family seminars, newsletters, online myeloma forum, electronics news alerts, and an international network of 87 myeloma-specific support groups. The IMF can be reached at www.myeloma.org or 800-452-CURE. |
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