Refusal to File from FDA for dovitinib, and its accompanying application for the DRP-Dovitinib companion diagnostic. Allerity Therapeutics,
Allarity Therapeutics, Inc. a clinical-stage pharmaceutical company developing novel oncology therapeutics together with drug-specific DRP companion diagnostics for personalized cancer care, announced that the FDA has 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”).
Upon preliminary review, the FDA determined that the NDA, submitted on December 22, 2021, and the PMA application, submitted on April 2, 2021, were not sufficiently complete to permit substantive reviews. In the letter regarding the NDA, the FDA’s cited reasons for the RTF decision primarily include, but are not limited to, that submitted clinical trial data do not enable a conclusion of efficacy based on non-inferiority data set. Given that the PMA and NDA were filed as related applications, the RTFs also apply to the DRP®-Dovitinib companion diagnostic.
Allarity intends to seek immediate guidance from the FDA, which potentially includes requesting a Type A meeting with the agency to clarify and respond to the issues identified in the RTF letters and seek additional guidance concerning information, data, and specific deliverables that the agency would require for a resubmitted NDA and PMA to be deemed complete. The Company anticipates that a new prospective clinical trial will be required to overcome the FDA’s outstanding objections.
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