Determination of Regulatory Review Period for Purposes of Patent Extension; XPOVIO, 30945-30947 [2021-12167]
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Federal Register / Vol. 86, No. 110 / Thursday, June 10, 2021 / Notices
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
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and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://
www.govinfo.gov/content/pkg/FR-201509-18/pdf/2015-23389.pdf.
Docket: For access to the docket to
read background documents or the
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received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
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You may submit comments on any
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Submit written requests for single
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and Drug Administration, 10001 New
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0002, or to the Office of
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the SUPPLEMENTARY INFORMATION section
for electronic access to the draft
guidance document.
FOR FURTHER INFORMATION CONTACT:
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Excellence, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 22, Rm. 2113, Silver Spring,
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and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 22, Rm. 2329, Silver Spring,
MD 20993–0002, 301–796–9628; or
Stephen Ripley, Center for Biologics
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301,
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Jkt 253001
Silver Spring, MD 20993–0002, 240–
402–7911.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Core Patient-Reported Outcomes in
Cancer Clinical Trials.’’ This draft
guidance provides recommendations to
sponsors regarding the collection of a
core set of PROs in cancer clinical trials
and related considerations for
instrument selection and trial design.
Although this draft guidance focuses on
PRO measures, some of the
recommendations may be relevant to
other clinical outcome assessments (i.e.,
clinician-reported outcome, observerreported outcome, performance
outcome) in cancer clinical trials. The
draft guidance is specific to registration
trials for anti-cancer therapies intended
to demonstrate an effect on survival,
tumor response, or delay in the
progression of a malignancy.
Cancer clinical trials typically employ
standardized efficacy assessment using
overall survival and tumor measures,
and safety assessments provided by
clinician reporting of adverse events.
FDA acknowledges the potential added
value of incorporating PRO
measurement of symptoms and
functional impacts into the benefit/risk
assessment in appropriately designed
trials; however, heterogeneity in PRO
assessment strategies has lessened the
regulatory utility of PRO data from
cancer trials. Systematic assessment of a
core set of PROs can facilitate high
quality data on patient-reported
symptoms and functional impacts. FDA
has previously described a core set of
PROs that may be important
contributors to a patient’s health-related
quality of life and that may be sensitive
to the effect of the disease and treatment
under study.1
FDA is issuing this draft guidance to
provide FDA’s current thinking on the
core PROs, considerations for
instrument selection to measure the core
PROs, trial design considerations such
as assessment frequency, and labeling
considerations. The core PROs
recommended in the draft guidance are
disease-related symptoms, symptomatic
adverse events, overall side effect
impact summary measure, physical
function, and role function.
This draft guidance is being issued
consistent with FDA’s good guidance
1 Kluetz, P.G., A. Slagle, E.J. Papadopoulos, et al.,
2016, ‘‘Focusing on Core Patient-Reported
Outcomes in Cancer Clinical Trials: Symptomatic
Adverse Events, Physical Function, and DiseaseRelated Symptoms,’’ Clinical Cancer Research,
22(7):1553–1558.
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30945
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the current thinking of FDA
on ‘‘Core Patient-Reported Outcomes in
Cancer Clinical Trials.’’ 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. Paperwork Reduction Act of 1995
While this guidance contains no
collection of information, it does refer to
previously approved FDA collections of
information. Therefore, clearance by the
Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995 (PRA) (44 U.S.C. 3501–
3521) is not required for this guidance.
The previously approved collections of
information are subject to review by
OMB under the PRA. The collections of
information in 21 CFR part 312 have
been approved under OMB control
number 0910–0014; the collections of
information in 21 CFR part 314 have
been approved under OMB control
number 0910–0001; and the collections
of information in 21 CFR part 601 have
been approved under 0910–0338.
III. Electronic Access
Persons with access to the internet
may obtain the draft guidance at either
https://www.fda.gov/drugs/guidancecompliance-regulatory-information/
guidances-drugs, https://www.fda.gov/
vaccines-blood-biologics/guidancecompliance-regulatory-informationbiologics/biologics-guidances, or https://
www.regulations.gov.
Dated: June 4, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–12166 Filed 6–9–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–E–5832]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; XPOVIO
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or the Agency) has
determined the regulatory review period
for XPOVIO and is publishing this
notice of that determination as required
SUMMARY:
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30946
Federal Register / Vol. 86, No. 110 / Thursday, June 10, 2021 / Notices
by law. FDA has made the
determination because of the
submission of an application to the
Director of the U.S. Patent and
Trademark Office (USPTO), Department
of Commerce, for the extension of a
patent which claims that human drug
product.
Anyone with knowledge that any
of the dates as published (see the
SUPPLEMENTARY INFORMATION section) are
incorrect may submit either electronic
or written comments and ask for a
redetermination by August 9, 2021.
Furthermore, any interested person may
petition FDA for a determination
regarding whether the applicant for
extension acted with due diligence
during the regulatory review period by
December 7, 2021. See ‘‘Petitions’’ in
the SUPPLEMENTARY INFORMATION section
for more information.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before August 9,
2021. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of August 9, 2021. Comments
received by mail/hand delivery/courier
(for written/paper submissions) will be
considered timely if they are
postmarked or the delivery service
acceptance receipt is on or before that
date.
DATES:
khammond on DSKJM1Z7X2PROD with NOTICES
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
VerDate Sep<11>2014
17:15 Jun 09, 2021
Jkt 253001
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand Delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2019–E–5832 for ‘‘Determination of
Regulatory Review Period for Purposes
of Patent Extension; XPOVIO.’’ Received
comments, those filed in a timely
manner (see ADDRESSES), will be placed
in the docket and, except for those
submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff between 9
a.m. and 4 p.m., Monday through
Friday, 240–402–7500.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with § 10.20 (21
CFR 10.20) and other applicable
disclosure law. For more information
about FDA’s posting of comments to
public dockets, see 80 FR 56469,
September 18, 2015, or access the
information at: https://
www.govinfo.gov/content/pkg/FR-201509-18/pdf/2015-23389.pdf.
PO 00000
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Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852, 240–402–7500.
FOR FURTHER INFORMATION CONTACT:
Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 51,
Rm. 6250, Silver Spring, MD 20993,
301–796–3600.
SUPPLEMENTARY INFORMATION:
I. Background
The Drug Price Competition and
Patent Term Restoration Act of 1984
(Pub. L. 98–417) and the Generic
Animal Drug and Patent Term
Restoration Act (Pub. L. 100–670)
generally provide that a patent may be
extended for a period of up to 5 years
so long as the patented item (human
drug product, animal drug product,
medical device, food additive, or color
additive) was subject to regulatory
review by FDA before the item was
marketed. Under these acts, a product’s
regulatory review period forms the basis
for determining the amount of extension
an applicant may receive.
A regulatory review period consists of
two periods of time: A testing phase and
an approval phase. For human drug
products, the testing phase begins when
the exemption to permit the clinical
investigations of the drug becomes
effective and runs until the approval
phase begins. The approval phase starts
with the initial submission of an
application to market the human drug
product and continues until FDA grants
permission to market the drug product.
Although only a portion of a regulatory
review period may count toward the
actual amount of extension that the
Director of USPTO may award (for
example, half the testing phase must be
subtracted as well as any time that may
have occurred before the patent was
issued), FDA’s determination of the
length of a regulatory review period for
a human drug product will include all
of the testing phase and approval phase
as specified in 35 U.S.C. 156(g)(1)(B).
FDA has approved for marketing the
human drug product, XPOVIO
(selinexor) indicated in combination
with dexamethasone for the treatment of
adult patients with relapsed or
refractory multiple myeloma who have
received at least four prior therapies and
whose disease is refractory to at least
E:\FR\FM\10JNN1.SGM
10JNN1
Federal Register / Vol. 86, No. 110 / Thursday, June 10, 2021 / Notices
khammond on DSKJM1Z7X2PROD with NOTICES
two proteasome inhibitors, at least two
immunomodulatory agents, and an antiCD38 monoclonal antibody. This
indication is approved under
accelerated approval based on response
rate. Continued approval for this
indication may be contingent upon
verification and description of clinical
benefit in a confirmatory trial.
Subsequent to this approval, the USPTO
received a patent term restoration
application for XPOVIO (U.S. Patent No.
8,999,996) from Karyopharm
Therapeutics Inc., and the USPTO
requested FDA’s assistance in
determining the patent’s eligibility for
patent term restoration. In a letter dated
January 21, 2020, FDA advised the
USPTO that this human drug product
had undergone a regulatory review
period and that the approval of XPOVIO
represented the first permitted
commercial marketing or use of the
product. Thereafter, the USPTO
requested that FDA determine the
product’s regulatory review period.
II. Determination of Regulatory Review
Period
FDA has determined that the
applicable regulatory review period for
XPOVIO is 2,585 days. Of this time,
2,253 days occurred during the testing
phase of the regulatory review period,
while 332 days occurred during the
approval phase. These periods of time
were derived from the following dates:
1. The date an exemption under
section 505(i) of the Federal Food, Drug,
and Cosmetic Act (FD&C Act) (21 U.S.C.
355(i)) became effective: June 6, 2012.
The applicant claims June 8, 2012, as
the date the investigational new drug
application (IND) became effective.
However, FDA records indicate that the
IND effective date was June 6, 2012,
which was the first date after receipt of
an earlier IND that the investigational
studies were allowed to proceed.
2. The date the application was
initially submitted with respect to the
human drug product under section 505
of the FD&C Act: August 6, 2018. The
applicant claims August 5, 2018, as the
date the new drug application (NDA) for
XPOVIO (NDA 212306) was initially
submitted. However, FDA records
indicate that NDA 212306 was
submitted on August 6, 2018.
3. The date the application was
approved: July 3, 2019. FDA has verified
the applicant’s claim that NDA 212306
was approved on July 3, 2019.
This determination of the regulatory
review period establishes the maximum
potential length of a patent extension.
However, the USPTO applies several
statutory limitations in its calculations
of the actual period for patent extension.
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In its application for patent extension,
this applicant seeks 291 days of patent
term extension.
III. Petitions
Anyone with knowledge that any of
the dates as published are incorrect may
submit either electronic or written
comments and, under 21 CFR 60.24, ask
for a redetermination (see DATES).
Furthermore, as specified in § 60.30 (21
CFR 60.30), any interested person may
petition FDA for a determination
regarding whether the applicant for
extension acted with due diligence
during the regulatory review period. To
meet its burden, the petition must
comply with all the requirements of
§ 60.30, including but not limited to:
must be timely (see DATES), must be
filed in accordance with § 10.20, must
contain sufficient facts to merit an FDA
investigation, and must certify that a
true and complete copy of the petition
has been served upon the patent
applicant. (See H. Rept. 857, part 1, 98th
Cong., 2d sess., pp. 41–42, 1984.)
Petitions should be in the format
specified in 21 CFR 10.30.
Submit petitions electronically to
https://www.regulations.gov at Docket
No. FDA–2013–S–0610. Submit written
petitions (two copies are required) to the
Dockets Management Staff (HFA–305),
Food and Drug Administration, 5630
Fishers Lane, Rm. 1061, Rockville, MD
20852.
Dated: June 3, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–12167 Filed 6–9–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2020–E–1325 and FDA–
2020–E–1324]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; WAKIX
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) has
determined the regulatory review period
for WAKIX and is publishing this notice
of that determination as required by
law. FDA has made the determination
because of the submission of
applications to the Director of the U.S.
Patent and Trademark Office (USPTO),
SUMMARY:
PO 00000
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30947
Department of Commerce, for the
extension of a patent which claims that
human drug product.
DATES: Anyone with knowledge that any
of the dates as published (see
SUPPLEMENTARY INFORMATION) are
incorrect may submit either electronic
or written comments and ask for a
redetermination by August 9, 2021.
Furthermore, any interested person may
petition FDA for a determination
regarding whether the applicant for
extension acted with due diligence
during the regulatory review period by
December 7, 2021. See ‘‘Petitions’’ in
the SUPPLEMENTARY INFORMATION section
for more information.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before August 9,
2021. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of August 9, 2021. Comments
received by mail/hand delivery/courier
(for written/paper submissions) will be
considered timely if they are
postmarked or the delivery service
acceptance receipt is on or before that
date.
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
E:\FR\FM\10JNN1.SGM
10JNN1
]]>Agencies
[Federal Register Volume 86, Number 110 (Thursday, June 10, 2021)]
[Notices]
[Pages 30945-30947]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-12167]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-E-5832]
Determination of Regulatory Review Period for Purposes of Patent
Extension; XPOVIO
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or the Agency) has
determined the regulatory review period for XPOVIO and is publishing
this notice of that determination as required
[[Page 30946]]
by law. FDA has made the determination because of the submission of an
application to the Director of the U.S. Patent and Trademark Office
(USPTO), Department of Commerce, for the extension of a patent which
claims that human drug product.
DATES: Anyone with knowledge that any of the dates as published (see
the SUPPLEMENTARY INFORMATION section) are incorrect may submit either
electronic or written comments and ask for a redetermination by August
9, 2021. Furthermore, any interested person may petition FDA for a
determination regarding whether the applicant for extension acted with
due diligence during the regulatory review period by December 7, 2021.
See ``Petitions'' in the SUPPLEMENTARY INFORMATION section for more
information.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before August 9, 2021. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of August 9, 2021. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2019-E-5832 for ``Determination of Regulatory Review Period for
Purposes of Patent Extension; XPOVIO.'' Received comments, those filed
in a timely manner (see ADDRESSES), will be placed in the docket and,
except for those submitted as ``Confidential Submissions,'' publicly
viewable at https://www.regulations.gov or at the Dockets Management
Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with Sec. 10.20 (21 CFR 10.20) and
other applicable disclosure law. For more information about FDA's
posting of comments to public dockets, see 80 FR 56469, September 18,
2015, or access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852, 240-402-7500.
FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 6250, Silver Spring, MD 20993, 301-796-3600.
SUPPLEMENTARY INFORMATION:
I. Background
The Drug Price Competition and Patent Term Restoration Act of 1984
(Pub. L. 98-417) and the Generic Animal Drug and Patent Term
Restoration Act (Pub. L. 100-670) generally provide that a patent may
be extended for a period of up to 5 years so long as the patented item
(human drug product, animal drug product, medical device, food
additive, or color additive) was subject to regulatory review by FDA
before the item was marketed. Under these acts, a product's regulatory
review period forms the basis for determining the amount of extension
an applicant may receive.
A regulatory review period consists of two periods of time: A
testing phase and an approval phase. For human drug products, the
testing phase begins when the exemption to permit the clinical
investigations of the drug becomes effective and runs until the
approval phase begins. The approval phase starts with the initial
submission of an application to market the human drug product and
continues until FDA grants permission to market the drug product.
Although only a portion of a regulatory review period may count toward
the actual amount of extension that the Director of USPTO may award
(for example, half the testing phase must be subtracted as well as any
time that may have occurred before the patent was issued), FDA's
determination of the length of a regulatory review period for a human
drug product will include all of the testing phase and approval phase
as specified in 35 U.S.C. 156(g)(1)(B).
FDA has approved for marketing the human drug product, XPOVIO
(selinexor) indicated in combination with dexamethasone for the
treatment of adult patients with relapsed or refractory multiple
myeloma who have received at least four prior therapies and whose
disease is refractory to at least
[[Page 30947]]
two proteasome inhibitors, at least two immunomodulatory agents, and an
anti-CD38 monoclonal antibody. This indication is approved under
accelerated approval based on response rate. Continued approval for
this indication may be contingent upon verification and description of
clinical benefit in a confirmatory trial. Subsequent to this approval,
the USPTO received a patent term restoration application for XPOVIO
(U.S. Patent No. 8,999,996) from Karyopharm Therapeutics Inc., and the
USPTO requested FDA's assistance in determining the patent's
eligibility for patent term restoration. In a letter dated January 21,
2020, FDA advised the USPTO that this human drug product had undergone
a regulatory review period and that the approval of XPOVIO represented
the first permitted commercial marketing or use of the product.
Thereafter, the USPTO requested that FDA determine the product's
regulatory review period.
II. Determination of Regulatory Review Period
FDA has determined that the applicable regulatory review period for
XPOVIO is 2,585 days. Of this time, 2,253 days occurred during the
testing phase of the regulatory review period, while 332 days occurred
during the approval phase. These periods of time were derived from the
following dates:
1. The date an exemption under section 505(i) of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(i)) became effective:
June 6, 2012. The applicant claims June 8, 2012, as the date the
investigational new drug application (IND) became effective. However,
FDA records indicate that the IND effective date was June 6, 2012,
which was the first date after receipt of an earlier IND that the
investigational studies were allowed to proceed.
2. The date the application was initially submitted with respect to
the human drug product under section 505 of the FD&C Act: August 6,
2018. The applicant claims August 5, 2018, as the date the new drug
application (NDA) for XPOVIO (NDA 212306) was initially submitted.
However, FDA records indicate that NDA 212306 was submitted on August
6, 2018.
3. The date the application was approved: July 3, 2019. FDA has
verified the applicant's claim that NDA 212306 was approved on July 3,
2019.
This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the USPTO
applies several statutory limitations in its calculations of the actual
period for patent extension. In its application for patent extension,
this applicant seeks 291 days of patent term extension.
III. Petitions
Anyone with knowledge that any of the dates as published are
incorrect may submit either electronic or written comments and, under
21 CFR 60.24, ask for a redetermination (see DATES). Furthermore, as
specified in Sec. 60.30 (21 CFR 60.30), any interested person may
petition FDA for a determination regarding whether the applicant for
extension acted with due diligence during the regulatory review period.
To meet its burden, the petition must comply with all the requirements
of Sec. 60.30, including but not limited to: must be timely (see
DATES), must be filed in accordance with Sec. 10.20, must contain
sufficient facts to merit an FDA investigation, and must certify that a
true and complete copy of the petition has been served upon the patent
applicant. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42,
1984.) Petitions should be in the format specified in 21 CFR 10.30.
Submit petitions electronically to https://www.regulations.gov at
Docket No. FDA-2013-S-0610. Submit written petitions (two copies are
required) to the Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
Dated: June 3, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-12167 Filed 6-9-21; 8:45 am]
BILLING CODE 4164-01-P
