80 FR 22526 - Clinical Trial Endpoints for the Approval of Non-Small Cell Lung Cancer Drugs and Biologics; Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 77 (April 22, 2015)

The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled ``Clinical Trial Endpoints for the Approval of Non-Small Cell Lung Cancer Drugs and Biologics.'' This guidance provides recommendations to applicants on endpoints for cancer clinical trials submitted to FDA to support effectiveness claims in new drug applications, biologics license applications, or supplemental applications for the treatment of non- small cell lung cancer. This guidance focuses on endpoints specifically for lung cancer trials to support drug approval or labeling claims. This guidance should speed the development and improve the quality of protocols submitted to FDA to support anticancer effectiveness claims. This guidance finalizes the draft guidance issued on June 17, 2011.

[Federal Register Volume 80, Number 77 (Wednesday, April 22, 2015)]
[Notices]
[Pages 22526-22527]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-09303]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-D-0432]


Clinical Trial Endpoints for the Approval of Non-Small Cell Lung 
Cancer Drugs and Biologics; Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a guidance for industry entitled ``Clinical Trial 
Endpoints for the Approval of Non-Small Cell Lung Cancer Drugs and 
Biologics.'' This guidance provides recommendations to applicants on 
endpoints for cancer clinical trials submitted to FDA to support 
effectiveness claims in new drug applications, biologics license 
applications, or supplemental applications for the treatment of non-
small cell lung cancer. This guidance focuses on endpoints specifically 
for lung cancer trials to support drug approval or labeling claims. 
This guidance should speed the development and improve the quality of 
protocols submitted to FDA to support anticancer effectiveness claims. 
This guidance finalizes the draft guidance issued on June 17, 2011.

DATES: Submit either electronic or written comments on Agency guidances 
at any time.

ADDRESSES: 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 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 20993-0002. 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.
    Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Rajeshwari Sridhara, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 21, rm. 3512, Silver Spring, MD 20993-0002, 301-
796-1759; or Stephen Ripley, Center for Biologics Evaluation and 
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
71, rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``Clinical Trial Endpoints for the Approval of Non-Small Cell 
Lung Cancer Drugs and Biologics.'' FDA is developing guidance on 
oncology endpoints through a process that includes public workshops of 
oncology experts and discussions before FDA's Oncologic Drugs Advisory 
Committee. This guidance provides background information and general 
principles. The endpoints discussed in this guidance are for drugs to 
treat patients with existing non-small cell lung cancer. This guidance 
does not address endpoints for drugs to prevent or decrease the 
incidence of cancer.
    This guidance finalizes the draft guidance for industry entitled 
``Clinical Trial Endpoints for the Approval of Non-Small Cell Lung 
Cancer Drugs and Biologics'' issued June 17, 2011 (76 FR 35450). 
Comments received from industry, professional societies, and consumer 
groups on the draft guidance have been taken into consideration by FDA 
in finalizing this guidance and some of the changes are summarized 
here. Sections II.A. and III. have been clarified based on the comments 
received and FDA's current thinking and practice regarding the 
magnitude of treatment effect based on progression-free survival. 
Appendices C and D have also been clarified based on the comments 
received and FDA's view on primary and sensitivity analyses of 
progression-free survival. The language in the guidance has been 
simplified to be concise.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
current thinking of FDA on clinical trial endpoints for the approval of 
non-small cell lung cancer drugs and biologics. 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. The Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of 
information that are subject to review by the Office of Management and 
Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520). The collections of information in 21 CFR parts 312, 314, and 601 
have been approved under OMB control numbers 0910-0014, 0910-0001, and 
0910-0338, respectively.

III. Comments

    Interested persons may submit either electronic comments regarding 
this document to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). It is only necessary to 
send one set of comments. Identify comments with the docket number 
found in brackets in the heading of this document. Received comments 
may be seen in the Division of Dockets Management between 9 a.m. and 4 
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

IV. Electronic Access

    Persons with access to the Internet may obtain the document at 
http://www.fda.gov/Drugs/

[[Page 22527]]

GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm, or http://www.regulations.gov.

    Dated: April 16, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-09303 Filed 4-21-15; 8:45 am]
BILLING CODE 4164-01-P