Regulatory path forward explored for dovitinib in renal cell carcinoma


Allarity Therapeutics, Inc., has requested a Type C meeting with the FDA to discuss a path forward with its multikinase inhibitor dovitinib for the treatment of patients with renal cell carcinoma (RCC).1

In December 2021, Allarity submitted a new drug application (NDA) to the FDA for the use of dovitinib as a third-line treatment for patients with RCC.2 However, in February 2022, the company received a Refusal to File letter from the FDA indicated that the NDA was substantially incomplete. Based on the letter, Allarity expects that the FDA will require a new prospective clinical trial for dovitinib.

“We look 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,” Steve Carchedi, chief executive officer of Allarity Therapeutics, Inc., stated in a press release. “With clarification from the 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.”

Roberto Pili, MD

Roberto Pili, MD

Roberto Pili, MD, associate dean for Cancer Research and Integrative Oncology at the University at Buffalo Jacobs School of Medicine and Biomedical Sciences, added in the press release, “I remain enthusiastic about dovitinib, together with its DRP-Dovitinib companion diagnostic, as a promising new treatment option for mRCC patients…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.”

Dovitinib data in RCC

Previously reported phase 3 data showed similar efficacy between third-line dovitinib and sorafenib (Nexavar), a standard treatment for RCC.3

The study included 570 patients with clear cell metastatic RCC who received 1 previous VEGF-targeted therapy and 1 previous mTOR inhibitor. Overall, there were 284 patients assigned to dovitinib and 286 assigned to sorafenib. The median progression-free survival was 3.7 months with dovitinib versus 3.6 months with sorafenib (HR, 0.86; 95% CI, 0.72-1.04; P = .063).


1. Allarity Therapeutics Provides Update on Dovitinib Program. Published online March 15, 2022. Accessed March 17, 2022.

2. Allarity Therapeutics Submits New Drug Application (NDA) to the U.S. FDA for Dovitinib for Third-Line Treatment of Renal Cell Carcinoma (RCC). Published online December 22, 2021. Accessed December 22, 2021.

3. Motzer RJ, Porta C, Vogelzang NJ, et al. Dovitinib versus sorafenib for third-line targeted treatment of patients with metastatic renal cell carcinoma: an open-label, randomised phase 3 trial. 2014;15(3):286-296. doi: 10.1016/S1470-2045(14)70030-0

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