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FDA places partial clinical hold on Celgene, MethylGene's cancer drug trials
Monday, August 18 2008 | Comments
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The Food and Drug Administration placed a partial clinical hold on the enrollment of new patients into trials of Celgene Corp. and MethylGene Inc.'s investigational cancer drug MGCD0103.In July, the companies voluntarily stopped new patient enrollment into MGCD0103 trials after researchers observed pericarditis or pericardial effusion in 19 patients of the approximately 400 patients treated at that time. The agency has subsequently agreed with the action and placed the partial hold until the companies submit data and an action plan intended to mitigate risk for patients.
The action plan is expected to include specific guidance on identifying patients at potential risk of pericarditis or pericardial effusion and on how to manage patients who may develop these conditions while undergoing treatment with the drug.
Despite the hold on enrollment, patients who are already enrolled in trials evaluating MGCD0103 who do not have signs or symptoms of pericarditis or pericardial effusion may continue in those trials.
As previously reported, investigators deemed approximately half of the reported cases of pericarditis or pericardial effusion as unlikely to be drug-related. The events tended to occur during the first cycle of treatment, the companies noted.
MGCD0103, an orally administered isoform-selective histone deacetylase inhibitor, is being evaluated as a combination treatment for solid tumors, hematological malignancies and pancreatic cancer as well as a monotherapy treatment for hematological malignancies.
The drug has been granted orphan drug status by the FDA for the treatment of Hodgkin's lymphoma and acute myelogenous leukemia.
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