Cascadian Therapeutics Inc (NASDAQ:CASC) gained around 16% in premarket deals after it secured fast track designation from the US Food and Drug Administration (FDA) for a cancer drug it is working on.
The fast track designation was granted for the ONT-380 program targeting advanced HER2+ metastatic breast cancer.
It comes as Cascadian is actively recruiting patients for a Phase 2 drug trial. Cascadian aims to recruit 180 patients.
“Fast Track designation recognizes the unmet medical need for this serious disease,” said Scott Myers, Cascadian chief executive.
“Many patients with metastatic HER2+ breast cancer will see their disease progress despite the availability and use of multiple targeted therapies.
“We are encouraged by the early evidence of systemic activity and activity against brain metastases, and the favorable tolerability profile with ONT-380 in combination studies.”
FDA fast track designation enables drug developers to expedite the review of drugs to treat serious conditions and fill an unmet medical need.
Valerie Fauvelle, Cascadian director of regulatory affairs, added: “Fast Track designation has the potential to reduce development time and cost associated with bringing a drug to patients.
“We look forward to working closely with the FDA to rapidly advance ONT-380 through the clinical development and regulatory process.”