FDA rejects Allarity's cancer candidate, demands more data
Allarity Therapeutics has received a firm no for its cancer drug candidate and its companion diagnostic device, dovitinib and DRP-Dovitinib, from the US health authority. A resubmission will require dialog with the FDA, the company says.
by ALBERT RØNNING-ANDERSSON, translated by daniel pedersen
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.
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