FDA Webinar: 60-Day Draft Guidance on Using an Endpoint to Support Accelerated Approval of Drugs to Treat Early-Stage Breast Cancer - June 28, 2012
On Thursday, June 28, 2012, FDA presented a webinar to discuss the new draft guidance for industry entitled, “Pathologic Complete Response in Neoadjuvant Treatment of High-Risk Early-Stage Breast Cancer: Use of an Endpoint to Support Accelerated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During this webinar, speakers from the Office of Hematology Oncology Products Breast Oncology Group discussed the new draft guidance for industry entitled, “Pathologic Complete Response in Neoadjuvant Treatment of High-Risk Early-Stage Breast Cancer: Use of an Endpoint to Support Accelerated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”.
This draft guidance was published in the May 30, 2012 Federal Register under Docket No. FDA–2012–D–0432].
This guidance 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). The objectives of the guidance are to:
- Propose a uniform definition of pCR for regulatory purposes.
- Briefly summarize what is currently known about the relationship between pCR and prognosis.
- Describe trial designs and patient populations where pCR is reasonably likely to predict clinical benefit.
- Provide guidance regarding trial designs that would permit confirmation of clinical benefit and support conversion to regular approval.
This guidance does not address trials of neoadjuvant endocrine therapy for breast cancer, nor does it address use of pCR as an endpoint for approval of drugs to treat tumor types other than breast cancer. This guidance describes one pathway to accelerated approval for promising drugs in early stages of development for breast cancer. Note that alternative approaches may be acceptable for drugs with more extensive prior clinical data, existing breast cancer indications, those being studied in ongoing randomized adjuvant breast cancer trials, or those with unprecedented efficacy in early breast cancer trials. Applicants should consult the FDA as early as possible regarding trial designs intended to support a neoadjuvant breast cancer indication.
Link to Guidance:
Guidance Webinar Online-Access Instructions: To access this webinar, follow the link provided below. Audio will broadcast from your computer speakers.
After following the link, enter as a guest and provide your FULL NAME and organization (i.e. "John Smith - FDA/CBER"). The host will then allow you to enter. If you experience technical difficulties email Jeffery.Rexrode@fda.hhs.gov for assistance. Closed captioning will be provided.
Questions/Comments can be submitted live via a Q/A chat window.
Access link: https://collaboration.fda.gov/guidancewebinars/
Download Presentation Slides: Pathologic Complete Response in Neoadjuvant Treatment of High-Risk Early-Stage Breast Cancer: Use of an Endpoint to Support Accelerated Approval (PDF - 208KB)
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