REGULATORY CORNER

As many of us are well aware, while single arm trials (SATs) historically have been accepted by the US FDA as primary evidence of efficacy for marketing approval in the setting of accelerated approval (AA) of new oncology agents/indications, their acceptance in other therapeutic areas including rare diseases has been more selective.

Draft Guidance - Clinical Trial Considerations to Support Accelerated Approval of Oncology Therapeutics

This guidance issued in March 2023 has been the subject of much talk. While in my opinion, it does not provide any new thoughts on the part of FDA regarding how they handle requests for approval using the accelerated approval (AA) pathway, it does put in writing the policies they have implemented in recent reviews and communications with sponsors.

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