FDA rejects Allarity's cancer candidate, demands more data

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.
Read the whole article
Get access for 14 days for free. No credit card is needed, and you will not be automatically signed up for a paid subscription after the free trial.
With your free trial you get:
- Access all locked articles
- Receive our daily newsletters
- Access our app