Two long-simmering and contentious issues associated with accelerated approval of cancer therapies bubbled to the surface at last week's Oncologic Drugs Advisory Committee meeting, exposing sharply different views about how FDA should seek to shape drug development.
One conflict centers on the level of efficacy, as well as the strength of data, the agency should require for approvals of new cancer therapies. A separate, but related, controversy involves FDA's decision to require products for accelerated approval to compete against off-label uses of approved drugs.
Near the end of ODAC's deliberations, Silvana Martino, the acting chair, steered the discussion away from the drug under consideration and into a more general debate over the goals of cancer drug development. Damning especially applications for accelerated approval, she complained that companies are "looking for the least amount of data to be convincing, and I think that is the wrong approach."
Martino, who heads the medical oncology breast section at the Cancer Institute Medical Group in Santa Monica, Calif., suggested that "as a medical community we have to rethink what our objectives