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April 16, 2003, Celgene’s (NYSE: CELG) Revmid (CC-5013) received fast track designation from the FDA for the treatment of myelodysplastic syndromes (MDS, refractory anemia). At last December’s American Society of Hematology meetings, Revmid generated preliminary, phase I/II evidence of clinical utility in the management of MDS. 9 of 16 evaluable patients (56%) were Revmid-responsive, achieving transfusion independence. Interim data analysis showed a median duration of response of at least 29 weeks. In addition, five patients experienced a platelet response, and five of eight patients (63%) with abnormal cytogenetics achieved a complete disappearance of abnormalities. Clinically relevant responses were also observed in terms of other markers of bone marrow and cytogenetic responsiveness. The magnitude of these responses requires clarification by further study.
Celgene plans to update these data at the International MDS Symposium May 15-18 in Paris. Revmid already has fast track status in the treatment of multiple myeloma. Currently, Revmid stands just behind Millennium’s (NASDAQ: MLNM) Velcade as the developmental agent most likely to significantly impact the future management of multiple myeloma.
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