Cascadian Therapeutics Inc (NASDAQ: CASC) shares towered over the competition after the Seattle-based company disclosed that it has been granted Orphan Drug Designation for Tucatinib for the treatment of colorectal cancer.
A release out Wednesday said the Food and Drug Administration’s Orphan Drug Designation program provides orphan status to drugs defined as those intended for the safe and effective treatment, diagnosis or prevention of rare diseases that affect fewer than 200,000 people in the United States.
Orphan designation qualifies the sponsor of the drug for certain development incentives, including tax credits for qualified clinical testing, prescription drug user fee exemption and seven-year marketing exclusivity upon FDA approval.
To quote CEO Scott Myers, “We are pleased to receive FDA orphan drug designation for tucatinib in HER2+ metastatic colorectal cancer, our second orphan designation in addition to breast cancer with brain metastases.
“We believe tucatinib has the potential to address unmet medical needs of patients in a broad range of HER2-positive cancers. We are currently supporting an investigator-initiated study evaluating tucatinib for the treatment of patients with HER2+ metastatic colorectal cancer.”
Colorectal cancer is the third-leading cause of cancer death in both men and women in the U.S. While the prevalence of HER2 amplified colorectal cancer varies depending on study methods and population, approximately 3% to 8% of these patients would be expected to potentially benefit from HER2-targeted therapy
Cascadian shares galloped 21 cents, or 5.4%, mid-morning Wednesday, to $4.08, within a 52-week trading range of $3.18 to $10.98.
