NEW YORK – Allarity Therapeutics said on Monday that the US Food and Drug Administration has accepted its premarket approval application for Dovitinib-DRP, the firm's gene expression-based companion diagnostic for selecting kidney cancer patients likely to respond to its lead therapy, dovitinib.
After reviewing the PMA, if the agency approves the DRP, or drug response predictor, it will facilitate renal cell cancer patients' access to dovitinib, if Allarity is successful in getting it to market. The Denmark-based company is planning to submit a new drug application with the FDA for dovitinib in this indication sometime this year.
Allarity, previously named Oncology Venture, licensed the tyrosine kinase inhibitor from Novartis after it failed to demonstrate a benefit for an all-comer kidney cancer population. Now, using the DRP platform as a companion diagnostic, Allarity hopes to identify patients who, based on a specific gene expression signature, are likely to respond to dovitinib.
The algorithm-based DRP platform uses cell-line data alongside gene expression and microarray data from patients' tumor samples to identify likely responders. In addition to using DRP as a companion test for dovitinib, Allarity is similarly using it to identify best responders to other in-licensed agents in its portfolio.
"[The FDA's acceptance] marks a turning point for our DRP technology, as it represents the first time in our company's history that we have advanced towards regulatory approval for one of our drug-specific DRP companion diagnostics," Allarity CEO Steve Carchedi said in a statement.