[Federal Register Volume 70, Number 63 (Monday, April 4, 2005)]
[Notices]
[Page 17095]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-6647]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2005D-0112]


Draft Guidance for Industry on Clinical Trial Endpoints for the 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availability of a draft guidance for industry entitled ``Clinical Trial 
Endpoints for the Approval of Cancer Drugs and Biologics.''
    This is the first of a series of guidances that will provide 
recommendations to sponsors on endpoints for cancer clinical trials 
submitted to FDA to support effectiveness claims in new drug 
applications (NDAs), biologics license applications (BLAs), or 
supplemental applications. Sponsors are encouraged to use this draft 
guidance to design cancer clinical trials and to discuss protocols with 
the agency. This draft guidance provides background information and 
discusses general regulatory principles. Each subsequent guidance will 
focus on endpoints for specific cancer types (e.g., lung cancer, colon 
cancer) to support drug approval or labeling claims. These guidances 
are expected to 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DATES: Submit written or electronic comments on the draft guidance by 
June 3, 2005. General comments on agency guidance documents are welcome 
at any time.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information (HFD-240), Center for Drug 
Evaluation and 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, Food and Drug Administration, 1401 Rockville Pike, 
Rockville, MD 20852-1448. Send one self-addressed adhesive label to 
assist that office in processing your requests. The draft guidance may 
also be obtained by mail by calling the Center for Biologics Evaluation 
and Research Voice Information System at 1-800-835-4709 or 301-827-
1800. Submit written comments on the draft 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 draft guidance 
document.

FOR FURTHER INFORMATION CONTACT:
    Grant Williams, Center for Drug Evaluation and Research (HFD-150), 
Food and Drug Administration, 1451 Rockville Pike, Rockville, MD 20852, 
301-594-5758;
    Patricia Keegan, Center for Drug Evaluation and Research (HFD-107), 
Food and Drug Administration, 1451 Rockville Pike, Rockville, MD 20852, 
301-827-5097; or
    Steven Hirschfeld, Center for Biologics Evaluation and Research 
(HFM-755), Food and Drug Administration, 1401 Rockville Pike, 
Rockville, MD 20852, 301-827-6536.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft 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 
draft guidance is the first in a planned series of cancer endpoint 
guidances. It provides background information and general principles. 
The endpoints discussed in this draft guidance are for drugs to treat 
patients with an existing cancer. This draft guidance does not address 
endpoints for drugs to prevent or decrease the incidence of cancer.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent 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. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments on the draft guidance. 
Submit one 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. The draft guidance and received 
comments are available for public examination in the Division of 
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

III. 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: March 26, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-6647 Filed 4-1-05; 8:45 am]
BILLING CODE 4160-01-S