NEW YORK – Allarity Therapeutics on Wednesday submitted a new drug application (NDA) to the US Food and Drug Administration for dovitinib for third-line treatment of renal cell carcinoma patients who have been selected by Allarity's Dovitinib-DRP companion diagnostic.
Allarity is seeking marketing approval for dovitinib alongside the companion test, which the company submitted for pre-market approval earlier this year. The Cambridge, Massachusetts-based firm licensed dovitinib from Novartis in 2018.
The DRP, or drug response predictor, companion diagnostic platform uses gene expression, microarray, and cell-line data from patients' tumor samples to identify likely responders to dovitinib. Allarity also uses its DRP platform to select patients who are likely to respond to its other oncology candidates.
In data from a Phase III trial in renal cell carcinoma patients selected by Dovitinib-DRP, patients who had a DRP score greater than 50 percent and received dovitinib had improved overall survival compared to those who received sorafenib (Bayer's Nexavar). Dovitinib-treated patients with a DRP score above 50 percent experienced a median overall survival of 15 months versus 11.2 months for those on sorafenib. Patients with DRP scores above 67 percent saw greater benefit, with median survival on dovitinib of 20.6 months.
Allarity is also studying dovitinib as a treatment for gastrointestinal stromal tumors, endometrial cancer, metastatic breast cancer, and hepatocellular carcinoma.