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.
CD123 x CD3 bispecific DART® antibody
Other Name: MGD006
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
Jan Baughman, MPH
Jan Davidson-Moncada, MD