The US Food and Drug Administration (FDA) has rejected Allarity Therapeutics’s marketing application for the cancer drug dovitinib and its accompanying diagnostics tool, DRP-dovitinib, a company press release reported late Friday night.
The applications were submitted on April 9 and December 22 last year, respectively, but the FDA has now determined that the data provided is insufficient, as it does ”not enable a conclusion of efficacy based on non-inferiority data set,” per the press release. The company gives no further details pertaining to what the FDA found inadequate about the filing.
Now, Allarity Therapeutics is strategizing about a new prospective clinical trial to ”overcome the FDA’s outstanding objections,” and the company says that it intends to seek immediate guidance from the agency to resolve the issues, paving the way for a resubmission.
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