Flotetuzumab Expanded Access Program

An Expanded Access Program Providing Flotetuzumab in the Treatment of Acute Myeloid Leukemia Patients in Single, Individually-approved Patients

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