FDA Commissioner Scott Gottlieb said Thursday that the agency is aiming to accelerate the approval of new medicines using very early data, with a particular focus on cancer drugs. "We might want to approve such a product earlier, and require a post-market confirmatory study to validate the finding – similar to an accelerated approval approach," Gottlieb remarked.
The Commissioner noted that the approach could be applied to treatments that appear to improve survival in only a small number of patients. "Even though the observed benefit, in this case, is on a clinical endpoint - an early look at survival - and not a surrogate measure of benefit, we believe using an accelerated approval approach often could be valuable," Gottlieb stated.
Further, Gottlieb noted that the FDA is "working on a similar proposal for cancer drugs already approved for one indication – approval for a supplemental application, where the approval concerns a second indication, can sometimes appropriately rely on a more targeted data set, like a single-arm study."
Since being confirmed as FDA Commissioner in May, Gottlieb has unveiled a number of initiatives to increase speed access to treatment and reduce drug prices. Gottlieb has called for the FDA to take steps to control drug pricing and indicated that the agency could take steps to hasten the availability of some generic drugs.
In June, the FDA announced the creation of a team to eliminate the backlog of orphan drug designation requests, while the agency later introduced measures to ease the authorisation of complex generics (for related analysis, see ViewPoints: FDA locks in on speedy approvals for complex generics.
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