On September 18, 2024 BriaCell Therapeutics Corp. (NASDAQ: BCTX, BCTXW) (TSX: BCT) ("BriaCell" or the "Company"), a clinical-stage biotechnology company that develops novel immunotherapies to transform cancer care, reported U.S. FDA (FDA) authorization of an Expanded Access Policy (EAP) for metastatic breast cancer (MBC) patients (Press release, BriaCell Therapeutics, SEP 18, 2024, View Source [SID1234646765]).

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FDA requires BriaCell to have an EAP policy, as a condition of granting BriaCell’s Fast Track designation , and to help MBC cancer patients in need of novel treatments. The EAP provides access to cancer patients beyond the scope of BriaCell’s pivotal Phase 3 trial (ClinicalTrials.gov as NCT06072612 ) to receive treatment with the Bria-IMT regimen.

"FDA authorization for the EAP highlights its awareness of the safety and efficacy profile of Bria-IMT and patients’ need to access such a novel treatment. While we are conducting our pivotal Phase 3 trial of Bria-IMT regimen with an immune checkpoint inhibitor, Bria-IMT may provide a treatment option for cancer patients in need," stated Dr. William V. Williams, BriaCell’s President and CEO. "Despite numerous approved drugs, breast cancer remains the second leading cause of cancer death in American women. With our novel immunotherapy, we expect to bring hope to patients and families suffering from this deadly disease."

"Given the recently reported impressive survival and clinical benefit of Bria-IMT regimen in metastatic breast cancer patients who failed multiple prior treatments, more patients would be able to benefit from the EAP with BriaCell’s novel immunotherapy approach," stated Giuseppe Del Priore, MD, MPH, BriaCell’s Chief Medical Officer. "We hope that our novel immunotherapy will become a new standard of care for metastatic breast cancer patients."