24-04-2018 16:40 via genengnews.com

FDA Imposes Partial Clinical Hold on Epizyme Lead Candidate after Patient Develops Lymphoma

The FDA has imposed a partial hold on U.S.-based enrollment of new patients in clinical trials of Epizyme’s lead candidate, the cancer treatment tazemetostat, after a patient in a Phase I pediatric study ( NCT02601937 ) developed a secondary lymphoma.Epizyme said the partial hold came after it submitted a safety report to the FDA and other regulators about the patient, who it acknowledged developed a secondary T-cell lymphoma. The patient “had advanced poorly differentiated chordoma,
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