FDA grants fast track designation to cellular immunotherapy for metastatic breast cancer
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The FDA granted fast track designation to Bria-IMT, an investigational cell-based therapy for the treatment of women with metastatic breast cancer.
Bria-IMT (SV-BR-1-GM, BriaCell Therapeutics) is a gene-edited, granulocyte-macrophage colony-stimulating factor-secreting breast cancer cell line derived from grade II biopsied tumor samples. The cells express HLA class I and class II antigens.
The cells are irradiated and given as an inoculation at four separate sites. Bria-IMT is provided as part of a regimen that includes low-dose cyclophosphamide before and interferon-alpha-2-beta after injection at each inoculation site.
Bria-IMT is currently being evaluated as part of a phase 1/phase 2A trial in women with recurrent or metastatic breast cancer who have received at least one previous line of therapy. The Bria-IMT regimen is being tested in combination with two other investigational therapies: retifanlimab — a PD-1 inhibitor (Incyte) — and epacadostat, an immunomodulator (Incyte).
The FDA's fast track designation helps to expedite development, review and potential approval of treatments for serious or life-threatening diseases. The regulator’s fast track approval for BriaIMT will apply to patients with metastatic breast cancer, according to a press release from the manufacturer.
“We are grateful for the opportunity to accelerate the development of our novel immunotherapy in advanced breast cancer,” Del Priore, MD, MPH, chief medical officer for BriaCell, said in a company-issued press release. “We continue to move forward with the clinical evaluation of Bria-IMT towards a potential registration study to bring hope to patients living with this deadly disease.”
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