According to a story from inpublic.globenewswire.com, the U.S. Food and Drug Administration has recently transferred its Orphan Drug designation for dovitinib from to Oncology Venture (OV) from Novartis, according to an announcement from OV. Dovitinib is in development for the treatment of rare adenoid cystic carcinoma. Oncology Venture is also developing a Drug Response Perdictor for dovitinib.
About Adenoid Cystic Carcinoma
Adenoid cystic carcinoma is a rare cancer type that can appear at many different sites of the body. Most commonly it appears in the salivary glands, but it also found in the trachea, lungs, brain, breasts, and lacrimal glands. Little is known about the causes of adenoid cystic carcinoma. The most common approach for treating this disease is typically surgical removal. This can be a challenge when the tumor is in the head or neck area, especially since this type of cancer tends to spread along nerve channels. Surgery is often accompanied by follow up radiation therapy. When surgery is not possible, fast neutron therapy is the most common alternative. Chemotherapy is typically reserved for metastatic disease. Five year survival rate is 89 percent, but this drops to just 40 percent at fifteen years, suggesting a risk of slow spreading, recurring tumors. To learn more about adenoid cystic carcinoma, click here.
About Dovitinib and the DRP
Dovitinib is classified as a tyrosine kinase inhibitor. The Drug Response Predictor (DRP), will be developed using data from clinical trials of the drug by comparing characteristics of patients that responded to the treatment to those that did not.
Orphan Drug Designation
Orphan Drug designation is reserved mostly for experimental therapies in the development for the treatment of diseases considered rare, or affecting less than 200,000 people in the US. The treatment must also fulfill a currently unmet medical need or display a substantive advantage in effectiveness over currently available treatments. The designation also confers certain benefits to the developer, such as a period of seven year market exclusivity if the therapy succeeds, the waiving of application fees, and some tax exemptions.
Overall, this experimental treatment could offer significant advantages to adenoid cystic carcinoma patients. In addition, dovitinib is also under trials for treating other forms of cancer as well, such as cancer of the liver and breast.
