FDA’s ODAC bind; plus NK cell engagers and company creation in Europe: a BioCentury podcast
After three days on trial at ODAC last week, FDA’s accelerated approval pathway awaits the agency’s verdict on six labels for checkpoint inhibitors that were discussed at the meeting. On the latest BioCentury This Week podcast, BioCentury’s editors assess whether the meeting outcomes will prompt FDA to revise the paradigm for accelerated approval of cancer therapies, as well as why NK cell engagers are gaining traction, and what’s the state of play for Europe’s newcos amid a banner year for money raising.
The integrity of the accelerated approval pathway was under the microscope at last week’s FDA’s Oncologic Drugs Advisory Committee. FDA presented justifications that could lead to the withdrawal of all six accelerated approvals. ODAC disagreed, recommending four be maintained.
FDA is in a difficult position, Washington Editor Steve Usdin explains. The agency could disregard some or all of ODAC’s recommendations, a decision that might infuriate patients. But if FDA complies with the recommendations, sponsors could conclude that they should decline agency suggestions to voluntarily withdraw accelerated approvals and press for the opportunity to make their case to ODAC. Usdin also explains why he does not believe FDA’s actions will read through to other disease areas.