Redefining Accelerated Approval Criteria Would Expand Pathway’s Use, Panel Says

26 Nov 2012

Expanding the definition of “unmet medical need” and adopting a narrow, molecularly targeted approach to determining the existence of “available therapies” would enable use of the approval pathway in earlier treatment settings, a group of stakeholders tells a cancer research conference.

Use of FDA’s accelerated approval pathway could be increased by broadening the definition of “unmet medical need” and narrowing the scope of what constitutes “available therapy,” a multi-stakeholder panel said at the Conference on Clinical Cancer Research Nov. 14.

Determining that any cancer setting in which no curative treatment exists constitutes an unmet medical need, and limiting the definition...