The Food and Drug Administration granted a fast-track designation to Bria-IMT for the treatment of patients with metastatic breast cancer.
The Food and Drug Administration (FDA) granted a fast-track designation to Bria-IMT (SV-BR-1-GM) for the treatment of patients with metastatic breast cancer, according to BriaCell Therapeutics, the developer of the cell-based immunotherapy drug.
By granting the fast-track designation, the FDA is agreeing to increase communication with the drug’s manufacturer and potentially approve the therapy earlier than it would have been without being fast-tracked.
“We are grateful for the opportunity to accelerate the development of our novel immunotherapy in advanced breast cancer. 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,” said Dr. Del Priore, BriaCell’s chief medical officer, in a press release.
A phase 1/2a clinical trial that is currently ongoing and still enrolling patients is examining Bria-IMT with retifanlimab (a checkpoint inhibitor) plus its immunomodulator (which properly activates the immune system for the drug to work), epacadostat.
Early data from the trial was presented in December 2021 at the San Antonio Breast Cancer Symposium and showed that the average progression-free survival (time from treatment until disease worsens) was 2.8 months for patients who received Bria-IMT alone, compared to 4.2 months for patients who received Bria-IMT plus checkpoint inhibition. Average overall survival was seven months for Bria-IMT monotherapy and 12 months for the combination regimen.
Bria-IMT is a cell-based therapy that expresses proteins that are found on breast cancer cells. The drug is engineered to spark an immune response by being taken up into dendritic (immune) cells that process the antigens bound to HLA molecules to the patient’s T cells, which will, in turn, attack the cancer cells, leaving healthy cells unharmed.
Overall, the researchers said that the drug was well-tolerated and that the ongoing study of Bria-IMT will focus on the patient populations who are likely to benefit most, which the data indicated may be patients with at least on HLA match and those with grade 1 or 2 tumors.
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