FDA Places Trials of MCL-1 Inhibitor on Clinical Hold

The U.S. Food and Drug Administration (FDA) has placed a clinical hold on a phase I, dose-escalation study of AMG 397, an oral, small molecule MCL-1 inhibitor being investigated for the treatment of multiple myeloma, non-Hodgkin lymphoma, or acute myeloid leukemia (AML). Amgen, the drug’s manufacturer, noted that the FDA instituted the hold after finding a safety signal of cardiac toxicity with the agent.

As a precaution, the pharmaceutical company also voluntarily halted a phase I study of the MCL-1 inhibitor AMG 176 in patients with AML.

While the exact nature of the safety signal was not disclosed, animal studies have suggested that the loss of MCL-1 activity can be associated with sudden onset heart failure.

Source: Amgen press release, September 12, 2019.