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)
Food and Drug Administration
Federal Register Volume 80, Issue 77 (April 22, 2015)
| Page Range | 22526-22527 | |
| FR Document | 2015-09303 |
[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] ----------------------------------------------------------------------- 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. ----------------------------------------------------------------------- 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 This guidance finalizes the draft guidance issued on June 17, 2011.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
![22526 Federal Register / Vol. 80, No. 77 / Wednesday, April 22, 2015 / Notices
Testimonies may also be submitted to and improve the quality of protocols Trial Endpoints for the Approval of
this email address: Paige.Hausburg@ submitted to FDA to support anticancer Non-Small Cell Lung Cancer Drugs and
acf.hhs.gov. Registration to attend the effectiveness claims. This guidance Biologics’’ issued June 17, 2011 (76 FR
consultation can be done using this link: finalizes the draft guidance issued on 35450). Comments received from
http://events.constantcontact.com/ June 17, 2011. industry, professional societies, and
register/event?llr=vt7m85dab&oeidk DATES: Submit either electronic or consumer groups on the draft guidance
=a07eau2syfc09b2fe8f. written comments on Agency guidances have been taken into consideration by
Please register by May 18, 2015, so at any time. FDA in finalizing this guidance and
that OCSE can include everyone ADDRESSES: Submit written requests for some of the changes are summarized
registered in the building access system single copies of this guidance to the here. Sections II.A. and III. have been
to assure their entry. OCSE is located in Division of Drug Information, Center for clarified based on the comments
a federal building and the security Drug Evaluation and Research, Food received and FDA’s current thinking
protocol requires government and Drug Administration, 10001 New and practice regarding the magnitude of
identification. Hampshire Ave., Hillandale Building, treatment effect based on progression-
OCSE understands that resources are free survival. Appendices C and D have
4th Floor, Silver Spring, MD 20993–
limited and travel may not be possible also been clarified based on the
0002; or Office of Communication,
for some tribal leaders. In order to comments received and FDA’s view on
engage as many tribal leaders as Outreach, and Development, Center for
Biologics Evaluation and Research, primary and sensitivity analyses of
possible, individuals who are unable to progression-free survival. The language
travel to Washington, DC, can connect Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, rm. in the guidance has been simplified to
to the meeting via a conference call. The be concise.
call-in number is 1–866–642–2926, 3128, Silver Spring, MD 20993–0002.
This guidance is being issued
participant passcode is 1436048. The Send one self-addressed adhesive label
consistent with FDA’s good guidance
URL for the webinar is: http:// to assist that office in processing your
practices regulation (21 CFR 10.115).
hhs.adobeconnect.com/drotribal/. To requests. See the SUPPLEMENTARY
The guidance represents the current
join by phone, please register using the INFORMATION section for electronic
thinking of FDA on clinical trial
link above. access to the guidance document.
Submit electronic comments on the endpoints for the approval of non-small
Dated: April 16, 2015. guidance to http://www.regulations.gov. cell lung cancer drugs and biologics. It
Donna Bonar, Submit written comments to the does not establish any rights for any
Deputy Commissioner, Office of Child Division of Dockets Management (HFA– person and is not binding on FDA or the
Support Enforcement. 305), Food and Drug Administration, public. You can use an alternative
[FR Doc. 2015–09351 Filed 4–21–15; 8:45 am] 5630 Fishers Lane, rm. 1061, Rockville, approach if it satisfies the requirements
BILLING CODE 4184–41–P MD 20852. of the applicable statutes and
regulations.
FOR FURTHER INFORMATION CONTACT:
Rajeshwari Sridhara, Center for Drug II. The Paperwork Reduction Act of
DEPARTMENT OF HEALTH AND Evaluation and Research, Food and 1995
HUMAN SERVICES Drug Administration, 10903 New This guidance refers to previously
Food and Drug Administration Hampshire Ave., Bldg. 21, rm. 3512, approved collections of information that
Silver Spring, MD 20993–0002, 301– are subject to review by the Office of
[Docket No. FDA–2011–D–0432] 796–1759; or Stephen Ripley, Center for Management and Budget (OMB) under
Biologics Evaluation and Research, the Paperwork Reduction Act of 1995
Clinical Trial Endpoints for the Food and Drug Administration, 10903
Approval of Non-Small Cell Lung (44 U.S.C. 3501–3520). The collections
New Hampshire Ave., Bldg. 71, rm. of information in 21 CFR parts 312, 314,
Cancer Drugs and Biologics; Guidance 7301, Silver Spring, MD 20993–0002,
for Industry; Availability and 601 have been approved under
240–402–7911. OMB control numbers 0910–0014,
AGENCY: Food and Drug Administration, SUPPLEMENTARY INFORMATION: 0910–0001, and 0910–0338,
HHS. respectively.
I. Background
ACTION: Notice.
FDA is announcing the availability of III. Comments
SUMMARY: The Food and Drug a guidance for industry entitled Interested persons may submit either
Administration (FDA or Agency) is ‘‘Clinical Trial Endpoints for the electronic comments regarding this
announcing the availability of a Approval of Non-Small Cell Lung document to http://www.regulations.gov
guidance for industry entitled ‘‘Clinical Cancer Drugs and Biologics.’’ FDA is or written comments to the Division of
Trial Endpoints for the Approval of developing guidance on oncology Dockets Management (see ADDRESSES).
Non-Small Cell Lung Cancer Drugs and endpoints through a process that It is only necessary to send one set of
Biologics.’’ This guidance provides includes public workshops of oncology comments. Identify comments with the
recommendations to applicants on experts and discussions before FDA’s docket number found in brackets in the
endpoints for cancer clinical trials Oncologic Drugs Advisory Committee. heading of this document. Received
submitted to FDA to support This guidance provides background comments may be seen in the Division
effectiveness claims in new drug information and general principles. The
asabaliauskas on DSK5VPTVN1PROD with NOTICES
of Dockets Management between 9 a.m.
applications, biologics license endpoints discussed in this guidance and 4 p.m., Monday through Friday, and
applications, or supplemental are for drugs to treat patients with will be posted to the docket at http://
applications for the treatment of non- existing non-small cell lung cancer. This www.regulations.gov.
small cell lung cancer. This guidance guidance does not address endpoints for
focuses on endpoints specifically for drugs to prevent or decrease the IV. Electronic Access
lung cancer trials to support drug incidence of cancer. Persons with access to the Internet
approval or labeling claims. This This guidance finalizes the draft may obtain the document at http://
guidance should speed the development guidance for industry entitled ‘‘Clinical www.fda.gov/Drugs/
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![Federal Register / Vol. 80, No. 77 / Wednesday, April 22, 2015 / Notices 22527
GuidanceCompliance list of premarket approval applications order approving, denying, or
RegulatoryInformation/Guidances/ (PMAs) that have been approved. This withdrawing approval of a PMA will
default.htm, http://www.fda.gov/ list is intended to inform the public of continue to include a notice of
BiologicsBloodVaccines/Guidance the availability of safety and opportunity to request review of the
ComplianceRegulatoryInformation/ effectiveness summaries of approved order under section 515(g) of the FD&C
default.htm, or http:// PMAs through the Internet and the Act. The 30-day period for requesting
www.regulations.gov. Agency’s Division of Dockets reconsideration of an FDA action under
Dated: April 16, 2015. Management. § 10.33(b) (21 CFR 10.33(b)) for notices
Leslie Kux, ADDRESSES: Submit written requests for announcing approval of a PMA begins
Associate Commissioner for Policy. copies of summaries of safety and on the day the notice is placed on the
[FR Doc. 2015–09303 Filed 4–21–15; 8:45 am] effectiveness data to the Division of Internet. Section 10.33(b) provides that
BILLING CODE 4164–01–P Dockets Management (HFA–305), Food FDA may, for good cause, extend this
and Drug Administration, 5630 Fishers 30-day period. Reconsideration of a
Lane, Rm. 1061, Rockville, MD 20852. denial or withdrawal of approval of a
DEPARTMENT OF HEALTH AND Please cite the appropriate docket PMA may be sought only by the
HUMAN SERVICES number as listed in table 1 when applicant; in these cases, the 30-day
submitting a written request. See the period will begin when the applicant is
Food and Drug Administration SUPPLEMENTARY INFORMATION section for notified by FDA in writing of its
[Docket Nos. FDA–2014–M–1452, FDA– electronic access to the summaries of decision.
2014–M–1596, FDA–2014–M–1597, FDA– safety and effectiveness. The regulations provide that FDA
2014–M–1599, FDA–2014–M–1735, FDA–
2014–M–1736, FDA–2014–M–2042, FDA–
FOR FURTHER INFORMATION CONTACT: publish a quarterly list of available
2014–M–2246, FDA–2014–M–2248, and Nicole Wolanski, Center for Devices and safety and effectiveness summaries of
FDA–2014–M–2376] Radiological Health, Food and Drug PMA approvals and denials that were
Administration, 10903 New Hampshire announced during that quarter. The
Medical Devices; Availability of Safety Ave., Bldg. 66, Rm. 1650, Silver Spring, following is a list of approved PMAs for
and Effectiveness Summaries for MD 20993–0002, 301–796–6570. which summaries of safety and
Premarket Approval Applications SUPPLEMENTARY INFORMATION: effectiveness were placed on the
AGENCY: Food and Drug Administration, Internet from October 1, 2014, through
I. Background December 31, 2014. There were no
HHS.
ACTION: Notice. In accordance with sections 515(d)(4) denial actions during this period. The
and (e)(2) of the Federal Food, Drug, and list provides the manufacturer’s name,
SUMMARY: The Food and Drug Cosmetic Act (the FD&C Act) (21 U.S.C. the product’s generic name or the trade
Administration (FDA) is publishing a 360e(d)(4) and (e)(2)), notification of an name, and the approval date.
TABLE 1—LIST OF SAFETY AND EFFECTIVENESS SUMMARIES FOR APPROVED PMAS MADE AVAILABLE FROM OCTOBER 1,
2014, THROUGH DECEMBER 31, 2014
PMA No., Docket No. Applicant Trade name Approval date
P040037/S060, FDA–2014–M–1452 ............... W.L. Gore & Associ- GORE VIABAHN Endoprosthesis, GORE September 19, 2014.
ates, Inc. VIABAHN Endoprosthesis with Heparin.
P070015/S122, FDA–2014–M–1596 ............... Abbott Vascular, Inc ... XIENCE V® and XIENCE nano® Everolimus October 3, 2014.
Eluting Coronary Stent System.
P110019/S066, FDA–2014–M–1596 ............... Abbott Vascular, Inc ... XIENCE PRIME® and XIENCE PRIME LL October 3, 2014.
Everlimus Eluting Coronary Stent System.
P130024, FDA–2014–M–1597 ......................... Lutonix, Inc ................. Lutonix 035 Drug Coated Balloon PTA Cath- October 9, 2014.
eter.
P110023/S007, FDA–2014–M–1599 ............... ev3, Inc ....................... EverFlexTM Self-Expanding Peripheral Stent October 10, 2014.
System.
P120005/S018, FDA–2014–M–1735 ............... Dexcom, Inc ............... Dexcom G4TM PLATINUM Continuous Glu- October 21, 2014.
cose Monitoring System.
P130026, FDA–2014–M–1736 ......................... St. Jude Medical ........ TactiCath Quartz® Catheter and October 24, 2014.
TactiSysQuartz® Equipment.
P120011, FDA–2014–M–2042 ......................... Ideal Implant, Inc ........ IDEAL IMPLANT® Saline-filled Breast Implant November 14, 2014.
P130007, FDA–2014–M–2246 ......................... Animas Corp .............. Animas Vibe System ....................................... November 25, 2014.
P140020, FDA–2014–M–2248 ......................... Myriad Genetic Lab- BRACAnalysis CDxTM .................................... December 19, 2014.
oratories, Inc.
P020012/S009, FDA–2014–M–2376 ............... Suneva Medical, Inc ... Bellafill ............................................................. December 23, 2014.
asabaliauskas on DSK5VPTVN1PROD with NOTICES
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Document Created: 2015-12-16 08:27:24
Document Modified: 2015-12-16 08:27:24
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Submit either electronic or written comments on Agency guidances at any time. | |
| 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. | |
| FR Citation | 80 FR 22526 |
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