New Drug Application Submitted to FDA for Dovitinib in Third-Line RCC

The new drug application for dovitinib as a third-line treatment for patients with renal cell carcinoma is supported by a pre-marketing approval for companion diagnostic, Dovitinib-DRP.

A new drug application has been submitted to the FDA for marketing approval of dovitinib as third-line therapy in in patients with renal cell carcinoma (RCC), according to a press release from developer Allarity Therapeutics.1

The application is supported by a previous pre-marketing approval submission for Dovitinib-DRP, a companion diagnostic for the agent that can select patients with RCC who are eligible and likely to respond to treatment with dovitinib.

“This [new drug application] 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,” Steve Carchedi, chief executive officer at Allarity Therapeutics, said in a press release.

The small molecule pan–tyrosine kinase inhibitor has previously demonstrated efficacy across a number of tumor types, including RCC, gastrointestinal stromal tumors, endometrial cancer, metastatic breast cancer, and hepatocellular carcinoma.

One phase 3 trial (NCT01223027) compared the use of dovitinib with sorafenib (Nexavar) as a third-line treatment for patients with metastatic RCC.2 In total, 284 patients received the experimental agent and 286 were randomized to the control arm. After a median follow-up of 11.3 months, investigators reported a median progression-free survival of 3.7 months (95% CI, 3.5-3.9) vs 3.6 months in the control arm (95% CI, 3.5-3.7; HR, 0.86; 95% CI, 0.72-1.04; one-sided P = .063).

Common grade 3/4 adverse effects (AE) in the dovitinib cohort included hypertriglyceridemia (14%), fatigue (10%), hypertension (8%), and diarrhea (7%). Additionally, 6% of those in the experimental arm had a serious AE of dyspnea compared with 5% in the sorafenib arm.

“As a clinical oncologist looking for new therapies for my [patients with] RCC, I am enthusiastic about Allarity’s [new drug application] filing together with its Dovitinib-DRP companion diagnostic,” Professor Roberto Pili, MD, associate dean for Cancer Research and Integrative Oncology at the University at Buffalo Jacobs School of Medicine and Biomedical Sciences, said in a statement. “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.”


  1. Allarity Therapeutics submits new drug application (NDA) to the U.S. FDA for dovitinib for third-line treatment of renal cell carcinoma (RCC). News release. Allarity Therapeutics. December 22, 2021. Accessed January 3, 2022.
  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. Lancet Oncol. 2014;15(3):286-296. doi:10.1016/S1470-2045(14)70030-0