FDA lifts partial clinical hold on Cell Therapeutics’ tosedostat

US biotech firm Cell Therapeutics (Nasdaq: CTIC) has received notification from the US Food and Drug Administration that the partial clinical hold on tosedostat (IND 075503) has been removed and all studies underway with the drug may continue.

The partial clinical hold was imposed last summer, when Cell Thera revealed that a patient, who was in their seventies and was being treated with tosedostat in combination with 5-azacitine or cytarabine on an investigator sponsored trial in patients with relapsed or refractory acute myeloid leukemia or high risk myelodysplastic syndrome (MDS), died of myocarditis (The Pharma Letter June 25, 2013).

The FDA requested additional data on patients treated with tosedostat, including additional information about the patient that died, a detailed review of all grades of cardiac adverse events or cardiac-related investigations in patients treated with tosedostat, as well as benefit-risk analysis based on the data presented.