In February and March, ASCO co-hosted several workshops with the FDA to discuss important topics in clinical trials:

• "Innovations in Breast Cancer Drug Development—Neoadjuvant Breast Cancer" included topics on how neoadjuvant trials can expedite drug development; the Collaborative Trials in Neoadjuvant Breast Cancer (CTNeoBC) meta-analysis results; and the draft "FDA Guidance for Industry: Use of Pathologic Complete Response in Neoadjuvant Treatment of High-Risk Early Stage Breast Cancer as an Endpoint to Support Accelerated Approval." ASCO President Sandra M. Swain, MD, FACP, and the FDA's Patricia Cortazar, MD, served as Co-Chairs of the workshop.

• Two workshops on minimal residual disease detection as a prognostic biomarker to that of an efficacy/response biomarker in evaluating new drugs for the treatment of chronic lymphocytic leukemia and acute myeloid leukemia provided a venue for an in-depth discussion of potential surrogate endpoints for trials intended to support the approval of new drugs or biologics.

Visit fda.gov/drugs/newsevents for more information.