AdCC Treatment Receives FDA Orphan Drug Designation


The FDA has granted orphan drug designation to Oncology Venture AB for their oral phase 3 multi tyrosine kinase inhibitor (previously TKI258), dovitinib DRP, for the treatment of adenoid cystic carcinoma (AdCC).

The US Food and Drug Administration (FDA) announced that it has transferred orphan drug designation from Novartis to Oncology Venture AB for oral phase 3 multi tyrosine kinase inhibitor (previously TKI258), dovitinib DRP, for the treatment of adenoid cystic carcinoma (AdCC).

AdCC is a rare form of adenocarcinoma that originates in glandular tissues. Approximately 1200 individuals are diagnosed with AdCC each year. The carcinoma often occurs in the major and minor salivary glands of the head and neck. Roughly 60% of individuals with AdCC are female. Of those who are affected, 89% have a 5-year survival rate, and 40% have a 15-year survival rate.

The dovitinib Drug Response predictor DRP is being developed through the use of existing data gleaned from patient's biopsies and clinical outcomes, according to a statement. Oncology Venture plans to use dovitinib DRP, “to both retrospectively and prospectively to identify patients that responded to treatment vs non-responders from the existing clinical trials.”

In 29 out of 37 clinical studies that were previously examined, dovitinib DRP displayed its ability to provide a statistically significant prediction of the clinical outcome of the treatment in patients. By screening patients’ tumor genes, only patients who are most likely to respond to treatment are treated. Consequently, risks and costs are reduced.

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