Official Title
An Expanded Access Program Providing Margetuximab in the Treatment of HER2+ Metastatic Breast Cancer in Single, Individually-approved Patients
Brief Summary

The purpose of the Expanded Access program is to provide margetuximab to patients with pretreated HER2+ breast cancer for whom potential benefit justifies potential treatment risks.

Detailed Description

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 margetuximab and

for MacroGenics to supply margetuximab for single patient use.

Status
Approved for marketing
EA Type
Individual Patients
Conditions
HER2-positive Breast Cancer
HER2-positive Carcinoma
Interventions

Biological: Margetuximab
anti-HER2 monoclonal antibody
Other Name: MGAH22

Eligibility Criteria

Inclusion Criteria: - MacroGenics may consider requests on a case-by-case basis from treating physicians for patients not otherwise eligible for margetuximab clinical studies. - Treating physicians should consider approved therapies for a patient's disease, as well as ongoing clinical studies, before seeking expanded access use with an investigational agent.

Exclusion Criteria:

Eligibility Gender
All
Sponsors / Collaborators
MacroGenics
NCT Number
NCT03133988
MeSH Terms
Breast Neoplasms
Margetuximab