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William J. Gradishar, MD, FACP, FASCO


FDA Brief: Cell-Based Immunotherapy Receives Fast Track Status in Metastatic Breast Cancer

By: Lauren Harrison, MS
Posted: Friday, April 15, 2022

BriaCell Therapeutics has recently announced that its cell-based immunotherapy, SV-BR-1-GM, has been given Fast Track status by the U.S. Food and Drug Administration (FDA) in the treatment of metastatic breast cancer. This therapy is a human breast cancer cell line with genetically engineered features of immune cells being developed in combination with immune checkpoint inhibitors.

A phase I/IIa clinical trial ( identifier NCT03328026), which is currently enrolling patients with advanced breast cancer who have failed to respond to two or more prior lines of therapy, will study the combination of SV-BR-1-GM, a PD-1 inhibitor, and an IDO inhibitor in patients with advanced breast cancer. Initial data from this study were presented at the 2021 San Antonio Breast Cancer Symposium. According to the manufacturer, survival was more than 12 months (average of nine prior regimens) with the novel therapy compared with 7 to 10 months in a study in the third-line setting of breast cancer. Other patient subsets who may benefit from treatment include those who match SV-BR-1-GM at one or more HLA type and those with grade I (well-differentiated) or grade II (moderately differentiated) breast cancer.

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