FDA Webinar: Draft Guidance on Using an Endpoint to Support Accelerated Approval of Early-Stage Breast Cancer Drugs

FDA Webinar: Draft Guidance on Using an Endpoint to Support Accelerated Approval of Early-Stage Breast Cancer Drugs

On Thursday, June 28, 2012, at 2:30 p.m. (ET), FDA will present a webinar to discuss the new draft guidance for industry entitled, Pathologic Complete Response in Neoadjuvant Treatment of High-Risk Early-Stage Breast Cancer: Use of an Endpoint to Support Accelerated Approval.

During this webinar, speakers from FDA's Office of Hematology Oncology Products Breast Oncology Group will discuss the draft guidance, which is intended to assist applicants in designing trials to support marketing approval of drugs to treat breast cancer in the Neoadjuvant (preoperative) setting. The main focus of the guidance is to discuss the use of pathologic complete response (pCR) in breast cancer as a potential endpoint to support approval under the accelerated approval regulations (21 CFR part 314, subpart H, for drugs and 21 CFR part 601, subpart E, for biological products).

http://www.gpo.gov/fdsys/pkg/FR-2012-05-30/pdf/2012-12928.pdf?source=govdelivery

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM305501.pdf?source=govdelivery

This draft guidance was published in the May 30, 2012 Federal Register (FR) under Docket No. FDA 2012 D 0432.



To access the draft guidance, visit http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM305501.pdf

FR Notice: http://www.gpo.gov/fdsys/pkg/FR-2012-05-30/pdf/2012-12928.pdf

Information about the draft guidance and webinar can be found at http://www.fda.gov/Drugs/ucm309182.htm