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TKI 258 filed with FDA for renal cell carcinoma.

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Published:23rd Dec 2021

Allarity Therapeutics announced the submission of a new drug application (NDA) with the FDA seeking marketing approval for TKI 258 (dovitinib) for the third-line treatment of renal cell carcinoma (RCC) patients.

The Company’s NDA filing is supported by its prior PMA submission with the FDA for use of Dovitinib-DRP, the Company’s validated companion diagnostic for the drug, to select and treat RCC patients most likely to respond to dovitinib.

Dovitinib is a small molecule, pan-tyrosine kinase inhibitor in-licensed from Novartis, and is Allarity’s most advanced clinical therapeutic candidate. The drug has previously shown clinical activity in a number of cancer indications, including RCC, gastrointestinal stromal tumors (GIST), endometrial cancer, metastatic breast cancer, and hepatocellular carcinoma (HCC). The Company expects to further evaluate the therapeutic benefit of dovitinib in one or more of these additional indications, either as a monotherapy or in combination with other oncology therapeutics.

Condition: Renal Cell Carcinoma

Type: drug

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