Allarity Therapeutics Submits Premarket Approval Application to U.S. FDA for DRP Companion Diagnostic for Dovitinib

- Submission precedes expected NDA filing for dovitinib in 2021
- Premarket Approval will allow U.S. marketing of DRP-Dovitinib as companion diagnostic to dovitinib

Press release

Hørsholm, Denmark (2 April 2021) Allarity Therapeutics A/S (“Allarity” or the “Company”) today announced the submission of a premarket approval application (PMA) to the U.S. Food and Drug Administration (FDA) for DRP-Dovitinib, the Company’s validated companion diagnostic for the drug dovitinib. Dovitinib is a small molecule, pan-tyrosine kinase inhibitor licensed from Novartis, and is Allarity’s most advanced clinical asset.  This milestone marks the first time that Allarity has sought regulatory approval for one of its drug-specific DRPs used to guide patient therapy.

Allarity’s unique DRP biomarker technology makes it possible to predict whether a particular cancer patient is likely to benefit from treatment with dovitinib, in addition to a broad range of anti-cancer drugs. DRP drug response assessments of the individual patients are done based on a biopsy from the patients’ tumors. The DRP-Dovitinib is intended to be used to identify patients, suffering from renal cell carcinoma (RCC), who by the gene expression signature of their tumor are found to have a high likelihood of responding to dovitinib.

Allarity plans to file a New Drug Application (“NDA”) with the FDA for the approval of dovitinib for the treatment of renal cell carcinoma (kidney cancer) during 2021. If the FDA provides the anticipated premarket approval of the dovitinib DRP as a companion diagnostic, as well as an NDA approval for dovitinib, Allarity will be able to market dovitinib to DRP-selected RCC patients as an effective new therapy to treat their disease.  The DRP for dovitinib, if approved, will be the first complex, gene expression signature approved by the U.S. FDA as a companion diagnostic to guide patient selection for cancer therapy.

Allarity’s CEO, Steve Carchedi, noted “Our current goal for dovitinib is to make it available to the group of RCC patients for whom a treatment with this particular therapeutic will be the most efficacious treatment for their disease. Today, marks a milestone for the advancement of our unique DRP biomarker technology for dovitinib, and approval of our PMA will enable oncologists to select those patients who are high likelihood responders to this drug.” Mr. Carchedi further stated: ”Later this year, I look forward to announcing our expected filing of a New Drug Application for dovitinib itself. Ultimately, if both of these filings are approved by the FDA, our Company will be positioned to significantly change how treatment of RCC will be conducted in the future, and help realize the promise of personalized medicine for these patients.”