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Federal Register / Vol. 86, No. 150 / Monday, August 9, 2021 / Notices
submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION. The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as confidential. Any information marked as confidential will not be disclosed except in accordance with 21 CFR 10.20
and other applicable disclosure law. For more information about FDAs posting of comments to public dockets, see 80
FR 56469, September 18, 2015, or access the information at: https
www.govinfo.gov/content/pkg/FR-201509-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https
www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the Search box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 2404027500.
You may submit comments on any guidance at any time see 21 CFR
10.115g5.
Submit written requests for single copies of this guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993
0002; or the Office of Communication, Outreach, and Development, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm.
3128, Silver Spring, MD 209930002.
Send one self-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY
INFORMATION section for electronic access to the guidance document.
FOR FURTHER INFORMATION CONTACT: Julia Beaver, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 2100, Silver Spring,
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MD 209930002, 2404020489; or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm 7268, Silver Spring, MD 209930002, 240
4027911.
SUPPLEMENTARY INFORMATION:
I. Background FDA is announcing the availability of a final guidance for industry entitled Nonmetastatic Castration-Resistant Prostate Cancer: Considerations for Metastasis-Free Survival Endpoint in Clinical Trials. Nonmetastatic castration-resistant prostate cancer nmCRPC is defined by rising prostatespecific antigen PSA despite castrate levels of testosterone and no radiographic evidence of distant metastatic disease. Despite earlier detection of localized prostate cancer and advances in surgical and radiation techniques, many patients will continue to have rising PSA after local therapy e.g., surgery, radiation for recurrent disease and subsequent androgen deprivation therapy. Patients with nmCRPC can have a prolonged disease course following the detection of a rising PSA until documentation of distant metastases or death. Such a prolonged assessment period in which patients may receive multiple therapies with low death rates may make the use of overall survival impractical as a primary endpoint to support approval of products in this disease setting.
These issues were discussed at an Oncologic Drugs Advisory Committee meeting in 2011, during which the committee acknowledged that endpoints that can be measured earlier in the course of disease, such as metastasisfree survival, defined as the time from randomization to distant radiographic disease or death, would be useful in assessing the treatment effect of products in patients with nmCRPC.
Additionally, the Oncologic Drugs Advisory Committee noted that the transition from nmCRPC to radiographically detectable metastatic disease e.g., bone disease or visceral disease is a clinically relevant event that can be associated with morbidity and the need for additional medical interventions. Conversely, local progression events may be treated with local therapies, may never progress to distant disease, and may not lead to systemic morbidity. Thus, a large treatment effect on metastasis-free survival with an acceptable safety profile could demonstrate clinical benefit and support product approval.
This guidance finalizes the draft guidance of the same title issued on
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November 14, 2018, 83 FR 56857.
Changes from the draft to the final include clarifying edits and expanding upon certain recommendations in the draft guidance.
This guidance is being issued consistent with FDAs good guidance practices regulation 21 CFR 10.115.
The guidance represents the current thinking of FDA on Nonmetastatic Castration-Resistant Prostate Cancer:
Considerations for Metastasis-Free Survival Endpoint in Clinical Trials. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.
II. Paperwork Reduction Act of 1995
While this guidance contains no collection of information, it does refer to previously approved FDA collections of information. Therefore, clearance by the Office of Management and Budget OMB under the Paperwork Reduction Act of 1995 PRA 44 U.S.C. 3501
3521 is not required for this guidance.
The previously approved collections of information are subject to review by OMB under the PRA. The collections of information in 21 CFR part 312 have been approved under OMB control number 09100014. The collections of information in 21 CFR parts 50 and 56
Protection of Human Subjects and Institutional Review Boards have been approved under OMB control number 09100130.
III. Electronic Access Persons with access to the internet may obtain the guidance at either https www.fda.gov/drugs/guidancecompliance-regulatory-information/
guidances-drugs, https www.fda.gov/
vaccines-blood-biologics/guidancecompliance-regulatory-informationbiologics, or https
www.regulations.gov.
Dated: August 2, 2021.
Lauren K. Roth, Acting Principal Associate Commissioner for Policy.
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