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The marketing application for a cancer drug has been rejected in the US due to insufficient testing data.
Adventrx Pharmaceuticals’ application concerning the drug ANX-530 (vinorelbine emulsion) was turned down by the US Food and Drug Administration (FDA), a result which could delay the drug’s registration programme for several months.
The FDA issued a “refusal-to-file” letter which said “data included in the initial submission from the intended commercial manufacturing site was insufficient to support a commercially-viable expiration dating period”.
The US agency, which has a preliminary 60-day period to decide whether there will be a full review of the dossier submitted after a New Drug Application (NDA) is submitted, decided that the US company’s application was not sufficiently complete.
Its ruling raises important questions concerning the way the FDA interprets requirements for stability data, said Adventrx’s chief executive Brian Culley.
Copyright Press Association 2010