Shots:

• The US FDA has placed a partial clinical hold on the P-Ib KOMET-001 study to evaluate Kura Oncology’s KO-539 in patients with r/r AML while patients who enrolled in this study will continue to receive KO-539 & no additional patients will enroll until the partial clinical hold is resolved
• The FDA’s decision is based on Kura’s recent report of a Grade 5 serious AEs (patient death) associated with differentiation syndrome
• The company is working closely with the US FDA and the site investigators to resolve the partial clinical hold shortly

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Ref: Kura Oncology | Image: Kura Oncology