FDA OKs BriaCell’s Pivotal Registrational Study Design in Advanced Metastatic Breast Cancer

 BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW) (TSX: BCT) (“BriaCell” or the “Company”), a clinical-stage immunotherapy company driven to fight cancer and improve patients’ lives, announces that it has received approval from FDA on its pivotal registrational study design for Bria-IMT™ in combination with a checkpoint inhibitor in advanced metastatic breast cancer.

FDA has approved the study design, the primary and secondary endpoints, and patient population in BriaCell’s upcoming pivotal registration clinical study. The study will include advanced metastatic breast cancer patients who have exhausted all other treatment options.

The trial will be a randomized, open-label study comparing the Bria-IMT™ combination regimen with an immune check point inhibitor in one arm with treatment of physicians’ choice in another arm in advanced metastatic breast cancer. A third smaller arm with the Bria-IMT™ regimen alone will be included in the study to address FDA’s combination drug assessment requirements. Upon achieving statistically significant milestones, BriaCell may apply for full approval of the Bria-IMT™ combination regimen following the Biologics Licensing Application (BLA) filing process.

https://www.biospace.com/article/releases/fda-approves-briacell-s-pivotal-registrational-study-design-in-advanced-metastatic-breast-cancer/