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.”