On March 15, 2022 Allarity Therapeutics, Inc. ("Allarity" or the "Company"), a clinical-stage pharmaceutical company developing novel oncology therapeutics together with drug-specific DRP companion diagnostics for personalized cancer care, reported an update on its lead dovitinib program (Press release, Allarity Therapeutics, MAR 15, 2022, View Source [SID1234610125]).
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On February 18, 2022, the Company announced that the U.S. Food and Drug Administration ("FDA") had provided the Company with Refusal to File ("RTF") letters regarding the new drug application ("NDA") for dovitinib, and its accompanying pre-market approval ("PMA") application for the DRP-Dovitinib companion diagnostic, for the third-line treatment of metastatic renal cell carcinoma ("mRCC"). In its announcement, Allarity stated that it intends to seek guidance concerning information, data, and specific deliverables that the agency would require for a resubmitted NDA and PMA to be deemed complete. The Company also stated that it anticipates that a new prospective clinical trial will be required to overcome the FDA’s outstanding objections.
Following several weeks of analysis by Company leadership together with clinical and regulatory experts, Allarity has now filed a formal request with the FDA for a "Type C" meeting to further discuss potential clinical paths to support approval of dovitinib, together with its DRP-Dovitinib companion diagnostic, in view of the FDA’s recent RTFs. According to FDA guidelines, "A Type C meeting is any meeting other than a Type A or Type B meeting between CBER or CDER and a sponsor or applicant regarding the development and review of a product." The Type C meeting is typically scheduled within 75 days of FDA receipt of the written meeting request. The Company anticipates providing a further update on the outcome of its FDA meeting and the future of the dovitinib program before the end of the third quarter of this year.
"Welook forward to working closely with the FDA and we remain highly confident in the clinical profile of dovitinib, together with the DRP-Dovitinib companion diagnostic. We are determined to further advance this product candidate as a potential new treatment option for cancer patients," said Allarity’s CEO Steve Carchedi. "With clarification fromthe FDA following our requested Type C meeting, we hope to have a clinical path forward with the goal of refiling our NDA and PMA once additional clinical data are in hand ."
" I remain enthusiastic about dovitinib, together with its DRP – Dovitinib companion diagnostic, as a promising new treatment option for mRCC patients , " 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. Although the landscape of treatment options for later-stage mRCC is evolving to include combination therapies, I continue to see a potential place for dovitinib with its DRP companion diagnostic in the treatment of these patients."