— Susan G. Komen®, the world’s leading breast cancer organization, further demonstrated its commitment to reducing breast cancer deaths as one of several organizations to help the Reagan-Udall Foundation and the Food and Drug Administration (FDA) develop the Expanded Access Navigator website. The new, online tool serves as a clearinghouse of information and resources about Expanded Access (EA), allowing patients and their doctors to more easily access information that could impact treatment decisions.

    EA, also known as “compassionate use,” provides access to an investigational drug prior to regulatory approval by the FDA for patients who have exhausted their treatment options and are not eligible for, or able to participate in, a clinical trial. The EA Navigator explains what EA is, who may be eligible, how the request process works, and the regulatory and policy issues around EA.

    “This program is literally a lifeline for patients who have tried treatment after treatment, and suddenly find themselves out of options,” said Komen interim President and CEO Ellen Willmott. “We are hopeful that this tool will make it easier for breast cancer physicians and patients to apply for, and benefit from, expanded access to investigational treatments.”

    Komen Advocates in Science member, breast cancer survivor and research professional, Stacy Woeppel, who contributed to the development of the tool, said of the experience, “I’ve known many patients who reach a point where they feel they have no recourse moving forward; no hope. It is rewarding to know that our efforts will educate and hopefully extend this program’s reach into the lives of many who need it.”

    Support of the EA Navigator is a step toward realizing Komen’s Bold Goal to reduce the current number of breast cancer deaths by 50 percent in the U.S. by 2026. 

    “Whether it’s in communities, in the halls of capitols or online – ensuring women and men have access to treatments that could save their lives is at the heart of all the work we do,” said Willmott. 

    Read more about the Expanded Access Navigator.