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Expanded Access to MacroGenics Investigational Products

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.

What is Expanded Access?

“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.

Does MacroGenics Consider Expanded Access Requests?

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.

  • At this time, MacroGenics is unable to make investigational products available outside a clinical trial.

What Does the Company Consider in Evaluating Requests?

Factors that the Company may consider when evaluating a request include, but are not limited to:

  • the clinical situation and need of the patient for which the treating physician seeks access, including whether the patient has a serious or life-threatening illness for which there is no viable alternative therapy;
  • whether the potential benefits of the experimental product may outweigh any potential risks;
  • whether regulatory authorities and institutional review boards/ethics committees have approved expanded access to the investigational product;
  • whether the product is under active development (that is, it is not an already approved product nor has the development program been discontinued);
  • whether the patient either is ineligible for or is unable to participate in a clinical trial for the investigational product;
  • the impact of providing access to an investigational product on the development program for that product, including the ability to complete patient enrollment and other aspects of the clinical trials necessary to secure product approval;
  • the supply needs of the investigational product for the development program;
  • the extent to which currently available data from early studies, including clinical studies, may be sufficient to make an assessment of the benefit and risk of the proposed use of the investigational product and for the patient to provide informed consent to such use; and
  • such other factors as MacroGenics may deem appropriate to consider from time to time, in its full discretion.

MacroGenics cannot guarantee access to any MacroGenics investigational agent and reserves the right to grant or deny a request in its full discretion.
MacroGenics reserves the right to revise these policy statements in whole or in part at any time, without notice.

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