Briacell Therapeutics Corp (NASDAQ: BCTX) has received U.S FDA Fast Track Designation for Bria-IMT. This therapy is for metastatic breast cancer. The company is now dosing and recruiting patients with the disorder to test for the efficacy of Bria-IMT in a Phase 1/2a clinical trial.
The study involves a combination of a checkpoint inhibitor from Incyte, retifanlimab and epacadostat, an immunomodulatory from the same company with Bria-IMT. Furthermore, the company initially presented information from the study in December. This study lasted 12 months which was more than another study on third-line patients with breast cancer that lasted seven months
According to the CEO of Briacell, Del Priore, M.D., the company is happy with the fast track designation as it gives it the chance to speed up the development and investigation of a drug that could potentially treat metastatic breast cancer. Moreover, the company wants to provide hope to patients with the disease.
Why the FDA grants fast track designation
The FDA grants the fast track designation to companies to accelerate the review and development of therapies that could treat severe diseases with high unmet needs. This designation allows patients with the disease to receive the drug promptly.
Different factors determine the severity of a disease. Typically, the FDA will consider things like the drug’s ability to improve a patient’s daily functioning and increase their survival. The regulator could also consider the progression of the disease if a patient doesn’t receive treatment.
How a company could earn the designation
If there are other available medications for the indication, a company has to show that its therapy is better to receive the designation. The company could show its superiority by establishing that it has less severe side effects. It can also show that it has better efficacy than current therapies.
Another way the company can prove that its therapy is superior is by indicating an oncoming public health need. The therapy could assess or point out flaws in the current therapy, including adverse effects that cause its discontinuation.
In addition, the company gains certain benefits from the designation. These include priority review and accelerated approval if the company meets the requirements. Another benefit is that the company gets faster and more frequent communication with the FDA.