Takeda Pharmaceuticals U.S.A., Inc.; Withdrawal of Approval of New Drug Application for EXKIVITY (Mobocertinib Succinate) Capsule, Equivalent to 40 Milligrams Base, 57418-57419 [2024-15371]
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Federal Register / Vol. 89, No. 135 / Monday, July 15, 2024 / Notices
ddrumheller on DSK120RN23PROD with NOTICES1
intended to give CBER regulatory
project managers and/or reviewers an
opportunity to tour biotechnology
manufacturing facilities developing
cellular and gene therapy products, and
to exchange regulatory experiences with
their industry counterparts. With this
program, CBER intends to enhance
review efficiency and quality by
providing CBER staff with a better
understanding of the biotechnology
manufacturing industry and its
operations. The purpose of this notice is
to invite companies developing cellular
and gene therapy products interested in
participating in this program to contact
OTP for more information.
DATES: Companies may send proposed
agendas to the Agency by August 14,
2024.
FOR FURTHER INFORMATION CONTACT: Lori
Tull, Office of Review Management and
Regulatory Review, Office of
Therapeutic Products, Center for
Biologics Evaluation and Research,
Food and Drug Administration, 240–
402–8361, Lori.Tull@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
Under section 351 of the Public
Health Service Act (PHS Act), FDA is
authorized to license biological
products if they have been
demonstrated to be ‘‘safe, pure, and
potent.’’ CBER is one of two Centers at
FDA that regulates biological products
for human use under applicable
statutory provisions of the PHS Act and
the Federal Food, Drug, and Cosmetic
Act (FD&C Act). Section 3033 of the 21st
Century Cures Act (Cures Act) (Pub. L.
114–255), was signed into law on
December 13, 2016, and amended
section 506 of the FD&C Act to
specifically address the expedited
development and review of certain
regenerative medicine therapies,
including cell therapies, therapeutic
tissue engineering products, and human
cell and tissue products.
An important part of CBER’s
commitment to make safe and effective
biological products available to all
Americans is optimizing the efficiency
and quality of the biologics review
process. To support this goal, CBER has
initiated various training and
development programs to promote high
performance in its regulatory project
management and review staff. OTP
seeks to enhance review efficiency and
review quality by providing staff with a
better understanding of the
biotechnology industry and its
operations. To this end, CBER/OTP is
offering regulatory project managers and
reviewers the opportunity to tour
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biotechnology manufacturing facilities.
The goals are to provide the following:
(1) firsthand exposure to industry’s
product development processes and (2)
a venue for sharing information about
project management best practices (but
not product-specific information) with
industry representatives.
II. The Interactive Site Tours Program
In this program, which may last a few
days, a small group of OTP regulatory
project managers and/or reviewers,
potentially also including senior level
staff, can observe operations of biologics
manufacturing and/or packaging
facilities, pathology/toxicology
laboratories, and regulatory affairs
operations. Neither this tour nor any
part of the program is intended as a
mechanism to inspect, assess, judge, or
perform a regulatory function, but is
meant rather to provide an avenue for
open dialogue between CBER/OTP staff
and industry representatives. During the
Interactive Site Tours Program,
regulatory project managers and
reviewers may also participate in daily
workshops with their industry
counterparts, focusing on selective
regulatory issues important to both OTP
staff and industry. The primary
objective of the daily workshops is to
understand the team approach to
biological product development,
including discovery, nonclinical and
clinical evaluation, postmarketing
activities, and regulatory submission
operations. The overall benefit to
regulatory project managers and
reviewers will be exposure to project
management, team techniques, and
processes employed by the
biotechnology industry. By participating
in this program, the regulatory project
managers and reviewers will gain a
better understanding of industry
processes and procedures.
III. Site Selection
All travel expenses associated with
the Interactive Site Tours Program will
be the responsibility of OTP; therefore,
selection of facility tour sites will be
based on the availability of funds and
resources for the program. Selection will
also be based on firms having a
favorable facility status as determined
by FDA’s Office of Regulatory Affairs
District Offices in the firms’ respective
locations. Firm participation in the
program is limited to companies
developing cellular and/or gene therapy
products. Firms that want to learn more
about this opportunity or that are
interested in offering a site tour should
respond by sending a proposed agenda
via email directly to Lori Tull (see DATES
and FOR FURTHER INFORMATION CONTACT).
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Dated: July 9, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–15351 Filed 7–12–24; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2024–N–3165]
Takeda Pharmaceuticals U.S.A., Inc.;
Withdrawal of Approval of New Drug
Application for EXKIVITY
(Mobocertinib Succinate) Capsule,
Equivalent to 40 Milligrams Base
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
withdrawing approval of the new drug
application (NDA) for EXKIVITY
(mobocertinib succinate) capsule,
equivalent to (EQ) 40 milligrams (mg)
base, held by Takeda Pharmaceuticals
U.S.A., Inc., 95 Hayden Ave., Lexington,
MA 02421 (Takeda). Takeda has
voluntarily requested that FDA
withdraw approval of this application
and has waived its opportunity for a
hearing.
DATES: Approval is withdrawn as of July
15, 2024.
FOR FURTHER INFORMATION CONTACT:
Kimberly Lehrfeld, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6226,
Silver Spring, MD 20993–0002, 301–
796–3137, Kimberly.Lehrfeld@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: On
September 15, 2021, FDA approved
NDA 215310 for EXKIVITY
(mobocertinib succinate) capsule, EQ 40
mg base, for the treatment of adult
patients with locally advanced or
metastatic non-small cell lung cancer
(NSCLC) with epidermal growth factor
receptor (EGFR) exon 20 insertion
mutations, as detected by an FDAapproved test, whose disease has
progressed on or after platinum-based
chemotherapy (EGFR exon 20 insertionmutated NSCLC), under the Agency’s
accelerated approval regulations, 21
CFR part 314, subpart H. The
accelerated approval of EXKIVITY
(mobocertinib succinate) capsule, EQ 40
mg base, for EGFR exon 20 insertionmutated NSCLC included a required
postmarketing trial intended to verify
the clinical benefit of EXKIVITY.
SUMMARY:
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Federal Register / Vol. 89, No. 135 / Monday, July 15, 2024 / Notices
On October 19, 2023, FDA met with
Takeda to discuss the voluntary
withdrawal of EXKIVITY (mobocertinib
succinate) capsule, EQ 40 mg base,
according to § 314.150(d) (21 CFR
314.150(d)). On October 25, 2023, FDA
recommended the applicant voluntarily
request withdrawal of approval of
EXKIVITY (mobocertinib succinate)
capsule, EQ 40 mg base, for EGFR exon
20 insertion-mutated NSCLC according
to § 314.150(d) because the
postmarketing trial did not verify
clinical benefit. FDA also requested
Takeda waive its opportunity for a
hearing.
On March 15, 2024, Takeda submitted
a letter asking FDA to withdraw
approval of NDA 215310 for EXKIVITY
(mobocertinib succinate) capsule, EQ 40
mg base, according to § 314.150(d) and
waiving its opportunity for a hearing.
For the reasons discussed above, and
in accordance with the applicant’s
request, approval of NDA 215310 for
EXKIVITY (mobocertinib succinate)
capsule, EQ 40 mg base, and all
amendments and supplements thereto,
is withdrawn under § 314.150(d).
Distribution of EXKIVITY (mobocertinib
succinate) capsule, EQ 40 mg base, into
interstate commerce without an
approved application is illegal and
subject to regulatory action (see sections
505(a) and 301(d) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C.
355(a) and 331(d)).
Dated: July 9, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–15371 Filed 7–12–24; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Advisory Council on Blood Stem Cell
Transplantation
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice.
AGENCY:
In accordance with the
Federal Advisory Committee Act, this
notice announces that the Advisory
Council on Blood Stem Cell
Transplantation (ACBSCT or Advisory
Council) has scheduled public meetings.
Information about the Advisory Council
and the agenda for these meetings can
be found on the ACBSCT website at
https://bloodstemcell.hrsa.gov/about/
advisory-council.
ddrumheller on DSK120RN23PROD with NOTICES1
SUMMARY:
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Thursday, August 22, 2024, 2:00
p.m.–6:00 p.m. Eastern Standard Time;
and Thursday, October 24, 2024, 2:00
p.m.–6:00 p.m. Eastern Standard Time.
ADDRESSES: Both meetings will be held
virtually by webinar. A link to register
and join each meeting will be posted at
least 10 days prior to the meeting date
at: https://bloodstemcell.hrsa.gov/
about/advisory-council.
FOR FURTHER INFORMATION CONTACT:
Shelley Tims Grant, Designated Federal
Official, HRSA Health Systems Bureau,
Division of Transplantation, 5600
Fishers Lane, 8W–67, Rockville,
Maryland 20857; 301–443–8036; or
ACBSCTHRSA@hrsa.gov.
SUPPLEMENTARY INFORMATION: ACBSCT
provides advice and recommendations
to the Secretary of Health and Human
Services on policy, program
development, and other matters of
significance concerning the activities
under the authority of 42 U.S.C. 274k
(Section 379 of the Public Health
Service Act), as amended, and Public
Law 109–129, as amended. The
Advisory Council may transmit its
recommendations through the HRSA
Administrator on matters related to the
activities of the C.W. Bill Young Cell
Transplantation Program and National
Cord Blood Inventory.
The agenda for the August 22, 2024,
meeting is being finalized and may
include the following topics: criteria for
defining a high-quality cord blood unit
for banking specifications; the unmet
needs in blood stem cell transplantation
and cellular therapy; updates on
transplant outcomes by different donor
sources; strategies to improve rates of
donation for adult blood stem cell
donors; and other areas to increase
blood stem cell donation and
transplantation. The agenda for the
October 24, 2024, meeting will be
determined based on discussion,
priorities, and/or action items from the
August 22, 2024, meeting. All agenda
items will be posted on the Advisory
Council’s website no later than 10 days
prior to the respective meeting dates.
Agenda items are subject to change as
priorities dictate. Interested individuals
are encouraged to monitor the Advisory
Council’s website for any updated
information concerning the meeting.
Members of the public will have the
opportunity to provide comments.
Public participants may submit written
statements in advance of the scheduled
meetings; oral comments will be
honored in the order they are requested
and may be limited as time allows.
Requests to submit a written statement
or make oral comments to ACBSCT
should be sent to Shelley Tims Grant,
DATES:
PO 00000
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57419
using the contact information above, at
least 3 business days prior to the
meeting.
Individuals who plan to attend and
need special assistance or other
reasonable accommodations should
notify Advisory Council at the address
and phone number listed above at least
10 business days prior to the meeting.
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2024–15391 Filed 7–12–24; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Submission to OMB for
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ACTION: Notice.
AGENCY:
In compliance with the
Paperwork Reduction Act of 1995,
HRSA submitted an Information
Collection Request (ICR) to the Office of
Management and Budget (OMB) for
review and approval. Comments
submitted during the first public review
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OMB will accept further comments from
the public during the review and
approval period. OMB may act on
HRSA’s ICR only after the 30-day
comment period for this notice has
closed.
DATES: Comments on this ICR should be
received no later than August 14, 2024.
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information collection should be sent
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PRAMain. Find this particular
information collection by selecting
‘‘Currently under Review—Open for
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FOR FURTHER INFORMATION CONTACT: To
request a copy of the clearance requests
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Collection Clearance Officer, at
paperwork@hrsa.gov or call (301) 443–
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SUPPLEMENTARY INFORMATION:
SUMMARY:
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]]>Agencies
[Federal Register Volume 89, Number 135 (Monday, July 15, 2024)]
[Notices]
[Pages 57418-57419]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-15371]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-N-3165]
Takeda Pharmaceuticals U.S.A., Inc.; Withdrawal of Approval of
New Drug Application for EXKIVITY (Mobocertinib Succinate) Capsule,
Equivalent to 40 Milligrams Base
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is
withdrawing approval of the new drug application (NDA) for EXKIVITY
(mobocertinib succinate) capsule, equivalent to (EQ) 40 milligrams (mg)
base, held by Takeda Pharmaceuticals U.S.A., Inc., 95 Hayden Ave.,
Lexington, MA 02421 (Takeda). Takeda has voluntarily requested that FDA
withdraw approval of this application and has waived its opportunity
for a hearing.
DATES: Approval is withdrawn as of July 15, 2024.
FOR FURTHER INFORMATION CONTACT: Kimberly Lehrfeld, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6226, Silver Spring, MD 20993-0002, 301-
796-3137, [email protected].
SUPPLEMENTARY INFORMATION: On September 15, 2021, FDA approved NDA
215310 for EXKIVITY (mobocertinib succinate) capsule, EQ 40 mg base,
for the treatment of adult patients with locally advanced or metastatic
non-small cell lung cancer (NSCLC) with epidermal growth factor
receptor (EGFR) exon 20 insertion mutations, as detected by an FDA-
approved test, whose disease has progressed on or after platinum-based
chemotherapy (EGFR exon 20 insertion-mutated NSCLC), under the Agency's
accelerated approval regulations, 21 CFR part 314, subpart H. The
accelerated approval of EXKIVITY (mobocertinib succinate) capsule, EQ
40 mg base, for EGFR exon 20 insertion-mutated NSCLC included a
required postmarketing trial intended to verify the clinical benefit of
EXKIVITY.
[[Page 57419]]
On October 19, 2023, FDA met with Takeda to discuss the voluntary
withdrawal of EXKIVITY (mobocertinib succinate) capsule, EQ 40 mg base,
according to Sec. 314.150(d) (21 CFR 314.150(d)). On October 25, 2023,
FDA recommended the applicant voluntarily request withdrawal of
approval of EXKIVITY (mobocertinib succinate) capsule, EQ 40 mg base,
for EGFR exon 20 insertion-mutated NSCLC according to Sec. 314.150(d)
because the postmarketing trial did not verify clinical benefit. FDA
also requested Takeda waive its opportunity for a hearing.
On March 15, 2024, Takeda submitted a letter asking FDA to withdraw
approval of NDA 215310 for EXKIVITY (mobocertinib succinate) capsule,
EQ 40 mg base, according to Sec. 314.150(d) and waiving its
opportunity for a hearing.
For the reasons discussed above, and in accordance with the
applicant's request, approval of NDA 215310 for EXKIVITY (mobocertinib
succinate) capsule, EQ 40 mg base, and all amendments and supplements
thereto, is withdrawn under Sec. 314.150(d). Distribution of EXKIVITY
(mobocertinib succinate) capsule, EQ 40 mg base, into interstate
commerce without an approved application is illegal and subject to
regulatory action (see sections 505(a) and 301(d) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 355(a) and 331(d)).
Dated: July 9, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-15371 Filed 7-12-24; 8:45 am]
BILLING CODE 4164-01-P
