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Allarity Therapeutics Seeks FDA Premarket Approval for Prediction Tool as CDx for Dovitinib

NEW YORK – Allarity Therapeutics said on Friday that it has submitted a premarket approval application to the US Food and Drug Administration for its DRP platform for use as a companion diagnostic alongside the kidney cancer drug dovitinib.

Allarity, formerly known as Oncology Venture, licensed the pan-tyrosine kinase inhibitor dovitinib from Novartis after it failed to demonstrate a benefit for an all-comer kidney cancer population. Now, Allarity plans to seek FDA approval for the drug in a biomarker-selected population of kidney cancer patients, as determined by the DRP.

The DRP platform, an algorithm-based tool that Allarity has developed specifically to repurpose the once-failed dovitinib, uses gene expression and microarray data to identify potential responders based on mRNA from biopsied tumor samples, and is rooted in cell line data. The company is also using a similar approach in the effort to repurpose other drugs that it has in-licensed, though dovitinib is its most mature clinical asset. The company is planning to file a new drug application for dovitinib with the FDA this year, and if both the drug and the DRP are approved, will market the treatment specifically to biomarker-selected renal cell carcinoma patients. The NDA was originally slated for the second half of 2020 but was pushed back due to pandemic-related manufacturing delays.