On July 5, 2021 Allarity Therapeutics A/S ("Allarity" or the "Company") reported that the U.S. Food and Drug Administration (FDA) has provided a positive administrative acceptance and review notification for the Company’s PMA application for its Dovitinib-DRP, the Company’s validated companion diagnostic for the drug dovitinib (Press release, Allarity Therapeutics, JUL 5, 2021, View Source [SID1234584595]). Dovitinib is a small molecule, pan-tyrosine kinase inhibitor in-licensed from Novartis, and is Allarity’s most advanced clinical asset.

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On 2 April, 2021, Allarity announced the filing of the PMA application. The FDA’s acceptance of the Company’s PMA application means that the FDA has made a threshold determination that the application is sufficiently complete to begin an in-depth review. Allarity’s PMA application, to gain FDA approval to use the Dovitinib-DRP as a companion diagnostic to select and treat patients likely to respond to dovitinib, supports the Company’s imminent NDA filing for the drug, and is the Company’s first PMA filing for a drug-specific DRP companion diagnostic.

Allarity’s CEO, Steve Carchedi, noted, "The FDA’s acceptance of our PMA filing for the Dovitinib-DRP companion diagnostic is an important milestone for our Company. This 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’s unique and clinically validated 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 for individual patients are done based on a biopsy from the patients’ tumor. The Dovitinib-DRP companion diagnostic 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 an NDA with the FDA for the approval of dovitinib for the treatment of renal cell carcinoma (kidney cancer) during 2021. If the FDA, following the agency’s complete review process, provides the anticipated PMA approval of the Dovitinib-DRP as a companion diagnostic for dovitinib, as well as an NDA approval for dovitinib, Allarity will be able to market dovitinib in the U.S. to DRP-selected RCC patients as an effective new therapy to treat their disease.