Many cancer patients unlikely to survive the disease are often neglected from oncology tests trialing new drugs; the FDA has posted new guidance hoping to boost inclusion of this often omitted group.
The U.S. agency, which has been making moves in this direction over the past few years, said in new, nonbinding guidance that patients with incurable cancers who have had prior drug therapies available on the market should be included for investigational studies of new oncology meds.
The short briefing document, which isn't yet final and merely shows the FDA’s “thinking” on the topic, said it wants to see: “Expansion of eligibility criteria such that, with appropriate informed consent, patients may be eligible for inclusion in trials of investigational drugs, including first-in-human trials, regardless of whether they have received available therapy in the non-curative setting.”
It adds that it also “encourages sponsors” to discuss their drug development plans with the regulator early in development, “including their approach to available therapy when developing eligibility criteria.”
The guidance is specifically aimed at those with terminal cancers, which the FDA says are “hematologic malignancies or solid tumors that are unresectable, locally advanced, or metastatic cancer with unfavorable long-term overall survival.”
Patients who have already taken marketed meds that may have cured them (but have failed to) were from the outset excluded from new trials of experimental drugs.