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MacroGenics is clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer.
The best way for MacroGenics to achieve these goals is to complete the clinical studies necessary to demonstrate safety and effectiveness of our investigational products. Patient enrollment in such clinical trials is essential for drug approval.
“Expanded access” programs are a means by which biopharmaceutical manufacturers may provide investigational products to physicians to treat seriously ill patients, in limited circumstances. Under an expanded access program, in such limited circumstances a company may provide an investigational product to physicians to administer to patients with limited to no therapeutic alternatives, who are ineligible or unable to participate in a clinical trial, and who may nonetheless desire access to an investigational product.
MacroGenics designs its clinical studies for development of new potential therapies to determine the safety and efficacy for medical use consistent with approval requirements of the US FDA and similar regulatory authorities in other countries. Treating physicians should consider approved therapies for a patient’s disease as well as on-going clinical studies before seeking expanded access use with an investigational agent.
However, MacroGenics may, on a case-by-case basis, consider requests by treating physicians to file an investigational new drug application for expanded access to MacroGenics investigational products in Phase 2 or Phase 3 of development and for MacroGenics to supply such investigational product. There is no guarantee of expanded access to an investigational product. For information about MacroGenics’ current investigational products in Phase 2 or Phase 3 of development, please visit ClinicalTrials.gov.
Factors that the Company may consider when evaluating a request include, but are not limited to:
MacroGenics cannot guarantee access to any MacroGenics investigational agent and reserves the right to grant or deny a request in its full discretion.
A treating physician may request to be contacted by MacroGenics personnel for information about expanded access to the investigational programs identified above by filling out and submitting the electronic form below.
MacroGenics reserves the right to revise these policy statements in whole or in part at any time, without notice.