Dovitinib application submitted to FDA for third-line renal cell carcinoma


Allarity Therapeutics has submitted a New Drug Application (NDA) to the FDA for use of the multikinase inhibitor dovitinib as a third-line treatment for patients with renal cell carcinoma (RCC).1

Support for the NDA comes from a prior submission from Allarity for premarket approval (PMA) of Dovitinib-DRP, the company’s companion diagnostic used to identify patients with RCC who are most likely to respond to dovitinib.

Roberto Pili, MD

Roberto Pili, MD

“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 companion diagnostic,” Roberto Pili, MD, associate dean for Cancer Research and Integrative Oncology at the University at Buffalo Jacobs School of Medicine and Biomedical Sciences, stated in a press release. “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."

Dovitinib data in RCC

Previously reported phase 3 data showed similar efficacy between third-line dovitinib and sorafenib (Nexavar), a standard treatment for RCC.2

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).

Commenting on the FDA application, Allarity’s CEO Steve Carchedi stated, “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.”


1. 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.

2. 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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