- BriaCell (BCT) receives FDA Fast Track approval for targeted breast cancer immunotherapy in the U.S.
- Food and Drug Administration (FDA) has granted Fast Track status to BriaCell’s lead candidate, Bria-IMT™, for the treatment of metastatic breast cancer
- BriaCell is currently enrolling and dosing advanced breast cancer patients in a Phase I/IIa study, now with Fast Track designation
- The FDA Fast Track is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need
- The clinical trial evaluates safety and efficacy of Bria-IMT, in combination with Incyte’s checkpoint inhibitor, retifanlimab, and its immunomodulator and more
- BriCell Therapeutics (BCT) is down 11.20 per cent, trading at C$11.20 at 2:52 pm ET
BriCell Therapeutics (BCT) has been granted Fast Track status for the treatment of metastatic breast cancer.
The Fast Track designation will apply to patients with metastatic breast cancer. BriaCell is developing Bria-IMT™ in combination with immune checkpoint inhibitors in a clinical trial.
BriaCell is currently enrolling and dosing advanced breast cancer patients in its Phase I/IIa combination study of Bria-IMT™ with Incyte’s checkpoint inhibitor, retifanlimab, and its immunomodulator, epacadostat, under corporate collaboration with Incyte.
Initial data on patient survival in this study was first presented at the San Antonio Breast Cancer Symposium in December 2021 and was over 12 months compared with seven to 10 months in a study (those who failed two prior regimens for metastatic breast cancer).
Other patient subsets with possible survival benefits included those who match Bria-IMT™ at one or more HLA types and those with grade I (well-differentiated) or grade II (moderately differentiated) 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.
The FDA Fast Track is designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill unmet medical needs.
The purpose is to get important new drugs to the patient earlier.
Determining whether a condition is serious is a matter of judgment but generally is based on whether the drug will have an impact on such factors as survival, day-to-day functioning, or the likelihood that the condition if left untreated, will progress from a less severe disease to a more serious one.
If there are available therapies, a Fast Track drug must show some advantage over available treatment, such as superior effectiveness, effect on serious outcomes or improved effect on serious outcomes.
In addition to the above, avoiding serious side effects of an available therapy is essential in the process as well.
With Fast Track designation, early and frequent communication between the FDA and a drug company is encouraged throughout drug development and review.
The frequency of communication assists with resolving issues quickly, potentially leading to earlier drug approval and access by patients.
Bria-IMT™ is cell-based immunotherapy designed to selectively destroy tumour cells without harming the normal cells.
The clinical trial evaluates the safety and efficacy of Bria-IMT™, in combination with Incyte’s checkpoint inhibitor, retifanlimab, and its immunomodulator, epacadostat, in patients with advanced breast cancer.
BriaCell is an immuno-oncology-focused biotechnology company developing targeted and effective approaches for cancer management.
BriCell Therapeutics (BCT) is down 11.20 per cent, trading at C$11.20 at 2:52 pm ET.
