Advaxis said the US Food & Drug Administration (FDA) had granted the designation for its ADXS-HER2 treatment for osteosarcoma.
Fast-track status was conceived in 1997 to speed up development of therapies for serious or life-threatening conditions for which there are no effective treatments.
The company’s products such as ADXS-HER2 are designed to harness the body’s ability to recognize and attack bacterial infections.
Advaxis’s core discovery – LM Technology – alters a live strain of listeria mono-cytogene bacteria to generate cancer-fighting T-cells.
Chief executive Daniel O’Connor said: “There are limited therapeutic treatment options available for this patient population, with no new treatments approved in over 20 years.
“ADXS-HER2 received orphan drug designation in 2015 from the FDA and EMA for the treatment of osteosarcoma.
“We believe that with these FDA-implemented incentive programs, like fast-track designation, patients are truly the benefactors.”
Shares in Advaxis rose 6.45% to US$8.58 in morning New York trading.