The purpose of the Expanded Access program is to provide flotetuzumab to patients with acute myeloid leukemia (AML) for whom potential benefit justifies potential treatment risks.

MacroGenics will consider, on a case-by-case basis, requests by treating physicians to file a single patient investigational new drug application for expanded access to flotetuzumab and for MacroGenics to supply flotetuzumab for single patient use.

Inclusion Criteria:

• Weight of at least 17 kilograms
• CD123-positive hematologic malignancy
• Adequate organ reserve
• Provider and site are trained on study protocol using flotetuzumab

Exclusion Criteria:

• AML that meets inclusion criteria for study CP-MGD006-01 (NCT02152956)
• Primary induction failure
• Early relapse (less than 6 months after first complete remission )
• Three prior lines of therapy, including maximum of 1 prior salvage attempts