80 FR 24262 - Endocrinologic and Metabolic Drugs Advisory Committee; Notice of Meeting

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 83 (April 30, 2015)

Page Range		24262-24263
FR Document		2015-10022

Federal Register, Volume 80 Issue 83 (Thursday, April 30, 2015)

[Federal Register Volume 80, Number 83 (Thursday, April 30, 2015)]
[Notices]
[Pages 24262-24263]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-10022]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-0001]


Endocrinologic and Metabolic Drugs Advisory Committee; Notice of 
Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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    This notice announces a forthcoming meeting of a public advisory 
committee of the Food and Drug Administration (FDA). The meeting will 
be open to the public.
    Name of Committee: Endocrinologic and Metabolic Drugs Advisory 
Committee.
    General Function of the Committee: To provide advice and 
recommendations to the Agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on June 10, 2015, from 8 
a.m. to 5 p.m.
    Location: Hilton Washington DC North/Gaithersburg, Grand Ballroom, 
620 Perry Pkwy., Gaithersburg, MD 20877. The hotel phone number is 301-
977-8900.
    Contact Person: Philip Bautista, Center for Drug Evaluation and 
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
31, Rm. 2417, Silver Spring, MD 20993-0002, 301-796-9001, FAX: 301-847-
8533, [email protected], or FDA Advisory Committee Information Line, 1-
800-741-8138 (301-443-0572 in the Washington, DC area). A notice in the 
Federal Register about last minute modifications that impact a 
previously announced advisory committee meeting cannot always be 
published quickly enough to provide timely notice. Therefore, you 
should always check the Agency's Web site at http://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate 
advisory committee meeting link, or call the advisory committee 
information line to learn about possible modifications before coming to 
the meeting.
    Agenda: The committee will discuss the safety and efficacy of 
biologics license application (BLA) 125522, proposed trade name REPATHA 
(established name: Evolocumab) for injection, submitted by Amgen Inc., 
as adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-
C), total cholesterol (TC), apolipoprotein B (ApoB), non-high-density 
lipoprotein cholesterol (non-HDL-C), TC/HDL-C, ApoB/ApoA1, very low-
density lipoprotein cholesterol, triglyceride, and lipoprotein A, and 
to increase HDL-C and ApoA1, in adults with hyperlipidemia or mixed 
dyslipidemia, either in combination with a statin or statin with other 
lipid-lowering therapies (e.g., ezetimibe), or alone, or in combination 
with other lipid-lowering therapies in patients who are statin-
intolerant, or alone or in combination with other lipid-lowering 
therapies in patients for whom a statin is not considered clinically 
appropriate. In addition, the committee will discuss the safety and 
efficacy of evolocumab to reduce LDL-C, TC, ApoB, and non-HDL-C, in 
combination with other lipid-lowering therapies (e.g. statins, LDL 
apheresis) in patients at least 12 years of age with homozygous 
familial hypercholesterolemia.
    FDA intends to make background material available to the public no 
later than 2 business days before the meeting. If FDA is unable to post 
the background material on its Web site prior to the meeting, the 
background material will be made publicly available at the location of 
the advisory committee meeting, and the background material will be 
posted on FDA's Web site after the meeting. Background material is 
available at http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting 
link.
    Procedure: Interested persons may present data, information, or 
views, orally or in writing, on issues pending before the committee. 
Written submissions may be made to the contact person on or before May 
27, 2015. Oral presentations from the public will be scheduled between 
approximately 1:15 p.m. to 2:15 p.m. Those individuals interested in 
making formal oral presentations should notify the contact person and 
submit a brief statement of the general nature of the evidence or 
arguments they wish to present, the names and addresses of proposed 
participants, and an indication of the approximate time requested to 
make their presentation on or before May 18,

[[Page 24263]]

2015. Time allotted for each presentation may be limited. If the number 
of registrants requesting to speak is greater than can be reasonably 
accommodated during the scheduled open public hearing session, FDA may 
conduct a lottery to determine the speakers for the scheduled open 
public hearing session. The contact person will notify interested 
persons regarding their request to speak by May 19, 2015.
    Persons attending FDA's advisory committee meetings are advised 
that the Agency is not responsible for providing access to electrical 
outlets.
    FDA welcomes the attendance of the public at its advisory committee 
meetings and will make every effort to accommodate persons with 
physical disabilities or special needs. If you require special 
accommodations due to a disability, please contact Philip Bautista at 
least 7 days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee 
meetings. Please visit our Web site at http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures 
on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: April 24, 2015.
Peter Lurie,
Associate Commissioner for Public Health Strategy and Analysis.
[FR Doc. 2015-10022 Filed 4-29-15; 8:45 am]
 BILLING CODE 4164-01-P

Federal Register / Vol. 80, No. 83 / Thursday, April 30, 2015 / Notices 24263

2015. Time allotted for each U.S. patent applications listed below • Personalized mutation-specific T
presentation may be limited. If the may be obtained by writing to the cells recognize mutations harboring
number of registrants requesting to indicated licensing contact at the Office tumor cells only and spare normal
speak is greater than can be reasonably of Technology Transfer, National tissues. This therapy has no tissue
accommodated during the scheduled Institutes of Health, 6011 Executive toxicities comparing to traditional
open public hearing session, FDA may Boulevard, Suite 325, Rockville, chemotherapy and radiotherapy.
conduct a lottery to determine the Maryland 20852–3804; telephone: 301– • The infusion of a highly pure
speakers for the scheduled open public 496–7057; fax: 301–402–0220. A signed population of these mutation-specific T
hearing session. The contact person will Confidential Disclosure Agreement will cells may maximize therapy and result
notify interested persons regarding their be required to receive copies of the in regression of all target lesions.
request to speak by May 19, 2015. patent applications.
Development Stage
Persons attending FDA’s advisory SUPPLEMENTARY INFORMATION:
committee meetings are advised that the Technology descriptions follow. • Early-stage
Agency is not responsible for providing • In vitro data available
access to electrical outlets. A Novel T Cell Therapy Against • In vivo data available (human)
FDA welcomes the attendance of the Patient-Specific Cancer Mutations • Ex vivo data available
public at its advisory committee Description of Technology: This Inventors: Eric Tran, Yong-Chen W.
meetings and will make every effort to invention is a novel T cell therapy Lu, Paul F. Robbins, Steven A.
accommodate persons with physical against cancer mutations that are patient Rosenberg (all of NCI).
disabilities or special needs. If you specific. Scientists at the National Publications
require special accommodations due to Institutes of Health have developed a
method to identify T cells that 1. Tran E, et al. Cancer immunotherapy
a disability, please contact Philip based on mutation-specific CD4+ T cells in
Bautista at least 7 days in advance of the specifically recognize immunogenic a patient with epithelial cancer. Science.
meeting. mutations expressed only by cancer 2014 May 9; 344(6184):641–5. [PMID
FDA is committed to the orderly cells. Human cancers contain genetic 24812403]
conduct of its advisory committee mutations that are unique to each 2. Robbins P, et al. Mining exomic
meetings. Please visit our Web site at patient. Some of the mutated peptides sequencing data to identify mutated antigens
http://www.fda.gov/Advisory are immunogenic, can be recognized by recognized by adoptively transferred tumor-
Committees/AboutAdvisoryCommittees/ T cells, and therefore, may serve as reactive T cells. Nat Med. 2013
ucm111462.htm for procedures on therapeutic targets. The inventors Jun;19(6):747–52. [PMID 23644516]
public conduct during advisory identified cancer-specific mutations 3. Tran E, et al. T-cell therapy against
cancer mutations. Oncotarget. 2014 Jul
committee meetings. from a patient with widely metastatic 15;5(13):4579–80. [PMID 25046408]
Notice of this meeting is given under cholangiocarcinoma by sequencing
the Federal Advisory Committee Act (5 tumor samples and comparing with Intellectual Property: HHS Reference
U.S.C. app. 2). normal cells. Using tandem minigene No. E–229–2014/0—PCT Application
constructs encoding all of the mutations No. PCT/US2014/058805 filed October
Dated: April 24, 2015.
expressed by a patient’s tumor, the 2, 2014.
Peter Lurie, Related Technology: HHS Reference
inventors identified T cells that
Associate Commissioner for Public Health No. E–233–2014/0—PCT Application
Strategy and Analysis. recognized the immunogenic mutations
from the same patient. These mutation- No. PCT/US2014/058796 filed October
[FR Doc. 2015–10022 Filed 4–29–15; 8:45 am] 2, 2014.
reactive T cells have the potential to
BILLING CODE 4164–01–P
eliminate the cancer cells while sparing Licensing Contact: Whitney A.
normal tissues since normal tissues do Hastings, Ph.D.; 301–451–7337;
not express the mutations. The hastingw@mail.nih.gov.
DEPARTMENT OF HEALTH AND Collaborative Research Opportunity:
HUMAN SERVICES inventors expanded these mutation-
reactive T cells in vitro, and infused a The National Cancer Institute, Surgery
highly pure population of these T cells Branch, is seeking statements of
National Institutes of Health capability or interest from parties
back into the same patient. The patient
Government-Owned Inventions; experienced tumor regression when she interested in collaborative research to
Availability for Licensing was treated with this approach. further develop, evaluate or
commercialize T-cell therapy against
AGENCY: National Institutes of Health, Potential Commercial Applications cancer mutations. For collaboration
HHS. • Personalized immunotherapy with opportunities, please contact Steven A.
ACTION: Notice. mutation-reactive T cells for mediating Rosenberg, M.D., Ph.D. at sar@nih.gov.
tumor regression in patients with A Novel, Personalized T Cell Therapy:
SUMMARY: The inventions listed below
immunogenic mutations. T-Cell Receptor Engineered T Cells
are owned by an agency of the U.S. • Mutation-reactive T cell therapy
Government and are available for Targeting Tumor Specific Mutations
especially beneficial for cancer patients
licensing in the U.S. in accordance with refractory to other therapies. Description of Technology: This
35 U.S.C. 209 and 37 CFR part 404 to • A research tool to identify patient- invention is a novel T cell therapy
achieve expeditious commercialization specific immunogenic mutations in the against cancer mutations that are patient
of results of federally-funded research
mstockstill on DSK4VPTVN1PROD with NOTICES

tumor. specific. Scientists at the National
and development. Foreign patent Institutes of Health have developed a
applications are filed on selected Competitive Advantages method to identify and generate T-cell
inventions to extend market coverage • This patient-specific therapy has receptor (TCR) engineered T cells for
for companies and may also be available the potential application to most personalized cancer therapy. The TCR is
for licensing. epithelial cancers, which account for a complex of integral membrane
FOR FURTHER INFORMATION CONTACT: about 90% of cancer deaths in the proteins that recognizes antigens and
Licensing information and copies of the United States. activates T cells. Human cancers

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Document Created: 2018-02-21 10:15:11
Document Modified: 2018-02-21 10:15:11

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.
FR Citation		80 FR 24262

80 FR 24262 - Endocrinologic and Metabolic Drugs Advisory Committee; Notice of Meeting

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 80, Issue 83 (April 30, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration