[Federal Register Volume 72, Number 94 (Wednesday, May 16, 2007)]
[Notices]
[Pages 27575-27576]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-9345]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2005D-0112]


Guidance for Industry on Clinical Trial Endpoints for the 
Approval of Cancer Drugs and Biologics; Availability

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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SUMMARY:  The Food and Drug Administration (FDA) is announcing the 
availability of a guidance for industry entitled ``Clinical Trial 
Endpoints for the Approval of 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. Applicants are encouraged to use this guidance to design 
cancer clinical trials and to discuss protocols with the agency. This 
guidance provides background information and discusses general 
regulatory principles. Additional companion guidances will follow and 
will focus on endpoints for specific cancer types (e.g., lung cancer, 
colon cancer) to support drug approval or labeling claims. This 
guidance, and the subsequent indication-specific guidances, should 
speed the development and improve the quality of protocols submitted to 
the agency to support anticancer effectiveness claims.

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

ADDRESSES:  Submit written requests for single copies of this guidance 
to the Division of Drug Information (HFD-240), Center for Drug 
Evaluation and

[[Page 27576]]

Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, 
MD 20857, or the Office of Communication, Training, and Manufacturers 
Assistance (HFM-40), Center for Biologics Evaluation and Research 
(CBER), Food and Drug Administration, 1401 Rockville Pike, suite 200N, 
Rockville, MD 20852-1448. Send one self-addressed adhesive label to 
assist that office in processing your requests. The guidance may also 
be obtained by mail by calling CBER at 1-800-835-4709 or 301-827-1800. 
Submit written comments on the guidance to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.fda.gov/dockets/ecomments. See the SUPPLEMENTARY INFORMATION 
section for electronic access to the guidance document.

FOR FURTHER INFORMATION CONTACT: 
    Rajeshwari Sridhara, Center for Drug Evaluation and Research, Food 
and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, rm. 1210, 
Silver Spring, MD 20903-0002, 301-796-2070; or
    Peter Bross, Center for Biologics Evaluation and Research (HFM-
755), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 
20852, 301-827-5378.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``Clinical Trial Endpoints for the Approval of 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 an existing cancer. This guidance does not address endpoints for 
drugs to prevent or decrease the incidence of cancer.
    The availability of a draft of this guidance was announced in the 
Federal Register of April 4, 2005 (70 FR 17095). 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. The section on 
future methods for assessing progression has been clarified based on 
the comments received and FDA's current thinking and practice. The 
section on no treatment or placebo control and the section on isolating 
drug effect in combination also have been clarified based on the 
comments received and FDA's view that these do not directly concern the 
selection or evaluation of endpoints. Throughout the guidance document, 
the language has been condensed and simplified to be concise and clear.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
agency's current thinking on clinical trial endpoints for the approval 
of cancer drugs and biologics. It does not create or confer any rights 
for or on any person and does not operate to bind FDA or the public. An 
alternative approach may be used if such approach 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 found in FDA regulations. These collections of information 
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 part 312 have been approved under 
0910-0014; the collections of information in 21 CFR part 314 have been 
approved under 0910-0001, and the collections of information referred 
to in the guidance for industry entitled ``Special Protocol 
Assessment'' have been approved under 0910-0470.

III. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding this document. 
Submit a single copy of electronic comments or two paper copies of any 
mailed comments, except that individuals may submit one paper copy. 
Comments are to be identified 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.

IV. Electronic Access

    Persons with access to the Internet may obtain the document at 
http://www.fda.gov/cder/guidance/index.htm, http://www.fda.gov/cber/guidelines.htm, or http://www.fda.gov/ohrms/dockets/default.htm.

    Dated: May 10, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-9345 Filed 5-15-07; 8:45 am]
BILLING CODE 4160-01-S