[Federal Register: April 4, 2005 (Volume 70, Number 63)]
[Notices]
[Page 17095]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr04ap05-90]

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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Draft Guidance for Industry on Clinical Trial Endpoints for the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availability of a draft guidance for industry entitled ``Clinical Trial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 Sponsors are encouraged to use this draft
guidance to design cancer clinical trials and to discuss protocols with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 This draft guidance provides background information and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DATES: Submit written or electronic comments on the draft guidance by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ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information (HFD-240), Center for Drug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 The draft guidance may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 Submit written comments on the draft guidance to the Division of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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cder/guidance/index.htm, http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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