NEW YORK – Allarity Therapeutics said on Friday that it has received Refusal to File letters from the US Food and Drug Administration in response to its new drug application for dovitinib and premarket approval application for the DRP-Dovitinib gene expression-based companion diagnostic.
Cambridge, Massachusetts-based Allarity filed an NDA for dovitinib late last year, seeking FDA approval for the tyrosine kinase inhibitor as a third-line treatment for metastatic renal cell carcinoma patients who the DRP companion diagnostic identified as most likely to benefit. The firm had filed a PMA for the DRP test last spring.
According to Allarity, the FDA does not consider the two applications "sufficiently complete to permit substantive reviews." The firm was seeking approval for dovitinib based on a non-inferiority data set, which the FDA did not feel reflected the drug's efficacy. Specifically, Allarity had taken a dataset from a trial in which dovitinib — previously a product of Novartis — had failed to benefit patients versus Bayer's Nexavar (sorafenib).
That trial had enrolled an all-comer population of kidney cancer patients, and Allarity performed a retrospective analysis using its CDx to show that patients with high DRP scores would benefit from the drug. The study was designed to show that dovitinib was not inferior to Nexavar in this patient population.
Allarity will seek further guidance from the FDA, possibly through a Type A meeting, on what additional data the FDA will need to see in order to accept its NDA and PMA applications for regulatory review. The company is anticipating the agency will ask for a prospective clinical trial demonstrating dovitinib's efficacy and safety.
Allarity CEO Steve Carchedi said in a statement that the firm remains confident that it will be able to advance dovitinib and the CDx in advanced renal cell cancer patients.