On December 22, 2021 Allarity Therapeutics, Inc. ("Allarity" or the "Company") (Nasdaq: ALLR) reported the submission of a new drug application (NDA) with the U.S. Food and Drug Administration (FDA) seeking marketing approval for dovitinib for the third-line treatment of renal cell carcinoma (RCC) patients (Press release, Allarity Therapeutics, DEC 22, 2021, View Source;U.S.-FDA-for-Dovitinib-for-Third-Line-Treatment-of-Renal-Cell-Carcinoma-RCC/default.aspx [SID1234597618]).
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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.
Allarity’s CEO Steve Carchedi noted, "This NDA submission for dovitinib, in connection with the Dovitinib-DRP companion diagnostic, is a historic milestone for our Company and an important step for late-stage renal cell carcinoma patients awaiting new treatment options. Over the past decade, we have worked diligently to advance our novel oncology therapeutics pipeline together with our unique DRP diagnostic technology to realize the promise of personalized cancer care for patients. We greatly look forward to the approval of dovitinib and to introducing the clinical value of DRP companion diagnostics to oncologists and their patients."
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.
"As a clinical oncologist looking for new therapies for my RCC patients, I am enthusiastic about Allarity’s NDA filing together with its Dovitinib-DRP(R) companion diagnostic," stated Professor Roberto Pili, M.D., Associate Dean for Cancer Research and Integrative Oncology at the University at Buffalo Jacobs School of Medicine and Biomedical Sciences. "These patients, and their treating oncologists, are greatly in need of new precision medicines, coupled with validated companion diagnostics, to help select and treat the most likely responders. I look forward to working with Allarity to advance this new personalized cancer care approach for RCC patients."
Allarity’s unique and clinically-validated DRP companion diagnostics platform enables the prediction of whether a particular cancer patient is likely to respond to treatment with dovitinib, in addition to a broad range of anti-cancer drugs. DRP drug response assessments for an individual patient are made based on a biopsy from the patient’s tumor. The Dovitinib-DRP companion diagnostic is intended to be used to identify patients with later-stage renal cell carcinoma (RCC) who, by the gene expression signature of their tumor, are identified as having a high likelihood of responding to dovitinib. By identifying and treating only those RCC patients most likely to respond to dovitinib, and avoiding treatment of those RCC patients likely to not respond to the drug, Allarity aims to improve treatment options for patients and their treating oncologist to improve therapeutic benefit.