Allarity Therapeutics Receives US FDA Acceptance and Review Notification for Dovitinib-DRP® Pre-Market Approval Request
Administrative aacceptance rsee mnotification from pre-mmarket aapproval (PMA) aapplication is the first step in several stages treat led by the FDA
MAP is submitted in support of an Imminent New Drug Application (NDA) for reovitinib
Hørsholm, Denmark (5 July 2021) – Allarity Therapeutics A / S (“Allarity” or the “Company”) today announced that the United States Food and Drug Administration (FDA) has provided administrative acceptance and positive review notification for the application. of the Company’s PMA for its Dovitinib-DRP®, the Company’s validated companion diagnosis for the drug dovitinib. Dovitinib is a small molecule, licensed pan-tyrosine kinase inhibitor from Novartis, and is Allarity’s most advanced clinical active ingredient.
On April 2, 2021, Allarity announced the filing of the assisted reproduction application. FDA acceptance of the Company’s PMA application signifies that the FDA has determined that the application is complete enough to begin a full review. Allarity’s PMA application, to obtain FDA approval to use Dovitinib-DRP® as a companion diagnostic to screen 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 diagnosis.
Allarity CEO Steve Carchedi said: “Ee FDA acceptance of our PMA file for the companion diagnosis Dovitinib-DRP® is an important step for our company. This marks a turning point for our DRP® Technology, As is represented the first time in our company’s history that we have moved towards regulatory approval for one of our drug-specific DRP® companion diagnostics.“
Allarity’s unique, clinically validated DRP® biomarker technology can predict whether a particular cancer patient is likely to benefit from treatment with dovitinib, in addition to a wide range of anticancer drugs. PRD® drug response assessments for individual patients are made based on a biopsy of the patients’ tumor. Dovitinib-DRP® Companion Diagnosis is intended to be used to identify patients with renal cell carcinoma (RCC) who, through their tumor gene expression signature, 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) in 2021. If the FDA, following the agency’s full review process, provides the planned PMA approval of 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 United States to RCC patients selected by DRP® as an effective new therapy to treat their disease.
About Allarity Therapeutic
Allarity Therapeutics (Nasdaq First North Growth Market Stockholm: ALLR.ST) develops personalized cancer treatment drugs guided by its proprietary drug response prediction technology, DRP® Platform. The company has a mature portfolio of six drug candidates, including compounds in the pre-registration phase. The product portfolio includes: Stenoparib (2X-121), a phase 2 PARP inhibitor for ovarian cancer; Dovitinib, a pan-TKI advancing to a US NDA dossier for renal cell carcinoma; IXEMPRA® (Ixabepilone), a microtubulin inhibitor approved in the United States for the treatment of breast cancer; LiPlaCis®, a liposomal formulation of cisplatin in phase 2 breast and prostate cancer trials; 2X-111, a liposomal formulation of doxorubicin being manufactured for phase 2 in breast cancer; and Irofulven, a phase 2 DNA damaging agent for prostate cancer. For more information, please visit the company’s website at www.Allarity.com
About the Drug Response Predictor – DRP® Companion diagnosis
Allarity uses its drug-specific DRP® to select patients who, through the genetic signature of their cancer, have a high probability of responding to the specific drug. By screening patients before treatment, the response rate can be dramatically increased. PRD® The method is based on the comparison of sensitive and resistant human cancer cell lines, including genomic information of cell lines combined with clinical tumor biology and results from previous clinical trials. PRD® is based on messenger RNA from patient biopsies. PRD® has proven its ability to provide a statistically significant prediction of the clinical outcome of drug therapy in cancer patients in nearly 40 clinical studies that have been reviewed, including an ongoing prospective phase 2 trial. PRD® The platform can be used in all types of cancer and is patented for more than 70 cancer drugs.
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This announcement includes forward-looking statements that involve risks, uncertainties and other factors, many of which are beyond Allarity’s control, and which could cause actual results to differ materially from the results discussed in the forward-looking statements. Forward-looking statements include statements about Allarity’s plans, objectives, goals, future events, performance and / or other information that are not historical information. All of these forward-looking statements are expressly qualified by these cautionary statements and any other cautionary statements that may accompany forward-looking statements. Allarity assumes no obligation to publicly update or revise any forward-looking statements to reflect events or circumstances subsequent to the date of publication, except as required by law.
Jens Knudsen, Chief Financial Officer
+45 8874 2415
Email inquiries: [email protected]
American media Contact:
Sam Brown, Inc.
EU Media contact:
Carrotize public relations and communications
+45 6062 9390
Svensk Kapitalmarknadsgranskning AB, Email: [email protected] Phone: +46 11 32 30 732
This information is information that Allarity A / S is obliged to make public under the EU Market Abuse Regulation. Information has been submitted for publication on 5 July 2021.