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FDA revises cancer vaccine guidance

Published on 12/10/09 at 02:14pm

There are concerns that draft guidance from the US Food and Drug Administration, which will recommend that cancer vaccine trials include healthy individuals as well as cancer patients, could slow down the clinical testing process.

The guidance - which is available to view online here - is designed to address the FDA's position that cancer vaccine studies present different considerations for trial design than traditional cytotoxic drugs or biologic products for cancer.

It applies to vaccines intended as therapeutics for cancer, and does not cover vaccines administered to patients to prevent or decrease the incidence of cancer.

The concern is that conventional cancer trials - which typically test new therapies' ability to retard disease progression in patients with late-stage cancer before progressive testing in earlier stages of disease - are inappropriate in the setting of cancer vaccines.

Indeed the FDA's draft guidance notes that, as the time between dosing of a therapeutic agent and disease progression can be quite short, "testing cancer vaccines using the conventional model may not allow time for development of an anti-tumour response needed for activity/effectiveness".

Commenting on the guidance, UK-based patient recruitment specialist Synexus said it had raised concerns among industry that the requirement would make it harder to carry out cancer vaccine trials, which are already posing significant challenges to sponsors.

While FDA guidance documents are not mandatory or enforceable, adhering to them can make bringing products through the registration process smoother.

"Concern has been expressed that cancer vaccine trials, which cannot recruit through the usual investigator channels, will take significantly longer than is the case today," said Synexus in a statement.

This will exacerbate the problems of cancer trials "failing to recruit their target numbers, being notoriously late to complete and burdening the sponsor with mounting costs," it added.

The FDA draft guidance is open for comments until December 17.


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