A little less ODAC

When FDA's Oncologic Drugs Advisory Committee last met on March 13, the committee's executive secretary announced that ODAC would not meet in June as planned. Some agency watchers concluded that there would be no major cancer drug approval announcements until fall.

While that would have been a good bet in the past, in this case it meant something else.

In May, FDA announced accelerated approval for Veclade bortezomib to treat relapsed and refractory multiple myeloma. The agency decided that Millennium Pharmaceuticals Inc. had slam-dunk data to support the safety and efficacy of Velcade based on a single-arm trial, so there was no need for an ODAC meeting.

The approval of Velcade, the first proteasome inhibitor, came about two months after the application was filed and less than a month before the canceled advisory committee meeting.

FDA's quick action allowed MLNM (Cambridge, Mass.) to ship the drug to hospitals by month's end. The agency easily could have met the six-month deadline for priority review even if had submitted Velcade for an ODAC review in June. But bypassing the panel sliced about a month off the review time.

A little faster, less transparent

In the 1990s, ODAC emerged as one of the busiest and most influential of the 20 committees that provide advice to the agency on biopharmaceuticals. Innovative science and flexible regulatory strategies combined to increase the number of NDAs and BLAs for cancer, pushing the agency to solicit ODAC's advice on almost all new products. In addition, the committee came to play a unique and unparalleled role as a disseminator of information and a peephole into the views of the oncology community.

Over the years, ODAC and the Center for Drug Evaluation and Research's cancer division have broken new ground together, including the use of surrogate markers to support accelerated approval, the inclusion of advisory committee members in decision making about the design of pivotal trials, and the addition of patient representatives on the committee.

But as part of its efforts to streamline review procedures, FDA has became more selective about which products it presents to ODAC. And as FDA launches new initiatives to better integrate the efforts by the academic research community, NIH and the biopharmaceutical industry to discover and develop new cancer therapies, the agency is relying increasingly on informal advice from outside experts, including individual members of the committee (see BioCentury, June 23).

Indeed, the agency solicited advice from several of the committee's clinicians when making decisions about

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