The Orphan Drug Designation awarded to the drug dovitinib for treating adenoid cystic carcinoma has been transferred from Novartis to Oncology Venture. The full article can be found here, at Globe Newswire.
About Adenoid Cystic Carcinoma
Adenoid cystic carcinoma (ACC) is a rare type of cancer that originates in the secretory glands. Although it usually occurs in the head and neck, it can also develop in other areas such as the breast, skin, or trachea. ACCs tend to be slow growing, but aggressive and can often reoccur. Approximately 1,200 are diagnosed with ACC each year in the United States, 60% of who are women.
About Dovitinib
Dovitinib is a tyrosine kinase inhibitor that, according to this article at Fierce Biotech, was originally being developed by Novartis, but has since been licensed to Oncology Venture. The Orphan Drug Designation awarded to dovitinib has now also been transferred from Novartis to Oncology Venture.
Oncology Venture is planning to develop the dovitinib Drug Response predictor DRP, which could be used to find out which patients responded to treatment and which didn’t in clinical trials. Oncology Venture is planning to analyse data from ACC patients to determine whether the indication of ACC is relevant for development.
Orphan Drug Designations
Orphan Drug Designations are awarded by the US FDA to drugs that are intended to treat, prevent, or diagnose rare conditions, defined as those that affect 200,000 or fewer people in the US. Drugs that are awarded the designation are eligible for several benefits, such as certain tax exemptions, waivers of some fees, and an extended period of marketing exclusivity. These benefits can support companies trying to develop medicines for rare conditions.
