Will FDA change the accelerated approval paradigm for cancer?
ODAC meeting poses challenges for FDA
ODAC meeting poses challenges for FDA.
The integrity of the accelerated approval pathway was on trial at the April 27-29 meeting of FDA’s Oncologic Drugs Advisory Committee, but the verdict won’t be clear until the agency announces and describes the actions it will take on the six accelerated approvals for checkpoint inhibitors that were discussed at the meeting.
The most important question is whether the meeting outcomes will prompt FDA to revise the paradigm for accelerated approval of cancer therapies.
FDA presented justifications that could lead to the withdrawal of all six accelerated approvals. ODAC disagreed, recommending four be maintained. The votes put FDA in a difficult position because the justifications ODAC members gave for maintaining some of the approvals are at odds with FDA’s accelerated approval paradigm.
The ODAC meeting was held at a time when Congress is being urged to consider modifying accelerated approval or creating economic disincentives for companies to use the pathway. The Institute for Clinical and Economic Review (ICER) has published a paper outlining proposals for “strengthening the accelerated approval pathway” and the Medicaid and CHIP Payment and Access Commission (MACPAC), a congressional agency, has recommended that Congress impose higher Medicaid rebates on drugs that receive accelerated