Articles tagged with: Immunomodulatory Agents

Press Releases»

[ by | Jul 18, 2013 7:30 am | Comments Off ]

Summit, NJ  (Press Release) - Celgene Corpo­ra­tion (NASDAQ: CELG) today announced that after consulta­tion with the U.S. Food and Drug Admin­istra­tion (FDA) Celgene will dis­con­tinue treat­ment with REVLIMID® (lena­­lido­mide) in the open-label, phase III ORIGIN® trial, which enrolled 450 patients in over 100 sites in 26 countries. An imbalance was observed in the number of deaths in patients treated with lenalido­mide versus patients treated with chlorambucil.

The FDA placed the ORIGIN study on clin­i­cal hold on July 12, 2013, with the dis­con­tinu­a­tion of lena­lido­mide treat­ment. All clin­i­cal investigators in ongoing chronic lym­pho­cytic leukemia studies using lena­lido­mide will be officially …

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Press Releases»

[ by | Jul 11, 2013 7:30 am | Comments Off ]

Statistically sig­nif­i­cant im­prove­ment in pro­gres­sion-free survival dem­onstrated

Phase III Study (MM-020/IFM 07-01) of Oral Revlimid (Lenalidomide) in Newly-Diagnosed Multiple Myeloma Meets Primary Endpoint Boudry, Switzerland (Press Release) - Celgene Inter­na­tional Sàrl, a wholly-owned sub­sid­i­ary of Celgene Corpo­ra­tion (NASDAQ: CELG), today announced that its phase III study (MM-020/IFM 07-01) of REVLIMID® (lena­lido­mide) in com­bi­na­tion with dexa­meth­a­sone in patients newly diag­nosed with multiple myeloma met its pri­mary end­point of pro­gres­sion-free survival (PFS). In the study, a doublet regi­men of continuous oral lena­lido­mide in com­bi­na­tion with low-dose dexa­meth­a­sone (Rd) dem­onstrated a statistically sig­nif­i­cant im­prove­ment in PFS compared to patients receiving a comparator arm with a triplet regi­men consisting of mel­phalan, pred­ni­sone and thalido­mide (MPT).

One of the largest phase III …

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