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` NDA 205552/S-029
`
` NDA 210563/S-004
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`
`
` SUPPLEMENT APPROVAL
`
`FULFILLMENT OF POST MARKETING REQUIREMENT
`
`
`
`
` Pharmacyclics LLC
`
` Attention: Preeti Sarde
`
` Manager, Regulatory Affairs
`
` 999 East Arques Avenue
`
` Sunnyvale, CA 94085-4521
`
`
`
`
` Dear Ms. Sarde:
`
`
`
`
`Please refer to your supplemental new drug applications (sNDAs) dated May 24, 2019,
`
`
`received May 24, 2019, and your amendments, submitted under section 505(b) of the
`
`
`Federal Food, Drug, and Cosmetic Act (FDCA) for IMBRUVICA (ibrutinib) capsules and
`
`tablets.
`
`
`
`
`
`These Prior Approval supplemental new drug applications provide for updates to the
`
`United States Prescribing Information Adverse Reactions section with long-term safety
`data from the final report for PMR 3038-01, entitled “Assessment of Safety Risks with
`
`Long-term use of IMBRUVICA® (Ibrutinib): A Post Marketing Requirement.”
`
`
`
`
`APPROVAL & LABELING
`
` We have completed our review of this application, as amended. It is approved, effective
`
`
`
`
` on the date of this letter, for use as recommended in the enclosed agreed-upon
`
` labeling.
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` CONTENT OF LABELING
`
`As soon as possible, but no later than 14 days from the date of this letter, submit the
`
`
`
`content of labeling [21 CFR 314.50(l)] in structured product labeling (SPL) format using
`
`
`the FDA automated drug registration and listing system (eLIST), as described at
`FDA.gov.1 Content of labeling must be identical to the enclosed labeling (text for the
`
`Prescribing Information), with the addition of any labeling changes in pending “Changes
`
`Being Effected” (CBE) supplements, as well as annual reportable changes not included
`
`
`
`in the enclosed labeling.
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`
`
`
` 1 http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm
`
`
`
`Reference ID: 4523408
`
`

`

`
`
`
` NDA 205552/S-029
`
` NDA 210563/S-004
`
` Page 2
`
`
` Information on submitting SPL files using eList may be found in the guidance for
`
`
` industry SPL Standard for Content of Labeling Technical Qs and As.2
`
`
`
`The SPL will be accessible from publicly available labeling repositories.
`
`
`
`Also within 14 days, amend all pending supplemental applications that include labeling
`
`
`changes for this NDA, including CBE supplements for which FDA has not yet issued an
`
`
`
`
`action letter, with the content of labeling [21 CFR 314.50(l)(1)(i)] in Microsoft Word
`
`
`format, that includes the changes approved in this supplemental application, as well as
`
`annual reportable changes. To facilitate review of your submission(s), provide a
`
`
`highlighted or marked-up copy that shows all changes, as well as a clean Microsoft
`
`Word version. The marked-up copy should provide appropriate annotations, including
`
`supplement number(s) and annual report date(s).
`
`REQUIRED PEDIATRIC ASSESSMENTS
`
`Under the Pediatric Research Equity Act (PREA) (21 U.S.C. 355c), all applications for
`
`
`new active ingredients (which includes new salts and new fixed combinations), new
`
`
`indications, new dosage forms, new dosing regimens, or new routes of administration
`
`are required to contain an assessment of the safety and effectiveness of the product for
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`
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`the claimed indication in pediatric patients unless this requirement is waived, deferred,
`
`or inapplicable.
`
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`Because none of these criteria apply to your application, you are exempt from this
`
`requirement.
`
`
`FULFILLMENT OF POSTMARKETING REQUIREMENT(S)/COMMITMENT(S)
`
`
`We have received your submission dated May 24, 2019, containing the final report for
`
`the following postmarketing requirement listed in March 4, 2016 (NDA 205552) approval
`
`
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`letter.
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`
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`
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`PMR 3038-1 Conduct a study to characterize the safety of long-term exposure to
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`Imbruvica based on data and pooled analyses from trials of patients
`
`
`with mantle cell lymphoma and chronic lymphocytic leukemia. Submit
`
`3-year, 4-year, and 5-year safety follow-up data and reports for a
`minimum population of 1000 patients treated with approved ibrutinib
`dosing regimens. Datasets should include patient-level data on
`ibrutinib dosing, treatment-emergent adverse events, and treatment-
`
`emergent laboratory information. This patient set may include
`
`approximately 350 patients who continue receiving long-term ibrutinib
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`
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`
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` 2 We update guidances periodically. For the most recent version of a guidance, check the FDA Guidance
`
` Documents Database https://www.fda.gov/RegulatoryInformation/Guidances/default.htm.
`
`
`
`
`U.S. Food and Drug Administration
`
`
`
`
`
`Silver Spring, MD 20993
`
`www.fda.gov
`
`
`
`Reference ID: 4523408
`
`

`

`
` NDA 205552/S-029
`
` NDA 210563/S-004
`
` Page 3
`
`
`
`
` therapy after completion of primary analysis of the parent study,
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` where study procedures are then limited to collect a minimum of
`
` Grade 3+ adverse events, available treatment emergent laboratory
`
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` data, adverse events leading to treatment discontinuation and SAEs.
`
`
` Study reports should include analyses of adverse event categories
` listed in the current Warnings and Precautions section of the
`
`
` prescribing information, adverse events leading to treatment
`
` discontinuation, and serious adverse events.
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`
`
`
`We have reviewed your submission and conclude that the above requirement was
`
`fulfilled.
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`
`This completes all of your postmarketing requirements and postmarketing commitments
`
`
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`acknowledged in our March 4, 2016 (NDA 205552) letter.
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`PROMOTIONAL MATERIALS
`
`You may request advisory comments on proposed introductory advertising and
`promotional labeling. To do so, submit the following, in triplicate, (1) a cover letter
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`requesting advisory comments, (2) the proposed materials in draft or mock-up form with
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`annotated references, and (3) the Prescribing Information to:
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`
`
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`OPDP Regulatory Project Manager
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`
`Food and Drug Administration
`
`
`Center for Drug Evaluation and Research
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`
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`Office of Prescription Drug Promotion (OPDP)
`
`
`5901-B Ammendale Road
`
`
`Beltsville, MD 20705-1266
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`
`
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`Alternatively, you may submit a request for advisory comments electronically in eCTD
`
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`format. For more information about submitting promotional materials in eCTD format,
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`
`see the draft guidance for industry Providing Regulatory Submissions in Electronic and
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`
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`Non-Electronic Format-Promotional Labeling and Advertising Materials for Human
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`Prescription Drugs.3
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`You must submit final promotional materials and Prescribing Information, accompanied
`by a Form FDA 2253, at the time of initial dissemination or publication
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`[21 CFR 314.81(b)(3)(i)]. Form FDA 2253 is available at FDA.gov.4 Information and
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`
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`
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`
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`
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` 3 When final, this guidance will represent the FDA’s current thinking on this topic. For the most recent
`
`
`
` version of a guidance, check the FDA guidance web page at
`
`
`
`
`
` https://www.fda.gov/RegulatoryInformation/Guidances/default.htm.
`
`4 http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM083570.pdf
`
`
`U.S. Food and Drug Administration
`
`
`
`Silver Spring, MD 20993
`
`
`
`www.fda.gov
`
`
`
`
`
`
`
`
`
`
`
`
`Reference ID: 4523408
`
`

`

`
` NDA 205552/S-029
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` NDA 210563/S-004
`
` Page 4
`
`
` Instructions for completing the form can be found at FDA.gov.5 For more information
`
`
`
`about submission of promotional materials to the Office of Prescription Drug Promotion
`(OPDP), see FDA.gov.6
`
`
`
` REPORTING REQUIREMENTS
`
`
`We remind you that you must comply with reporting requirements for an approved NDA
`
`
`(21 CFR 314.80 and 314.81).
`
`
`
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`If you have any questions, contact Patricia Garvey, Lead Regulatory Project Manager,
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`at (301) 796-8493.
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`
`
`
`
`Sincerely,
`
`
`{See appended electronic signature page}
`
`
`Ann T. Farrell, MD
`
`Director
`
`Division of Hematology Products
`
`Office of Drug Evaluation I
`
`
`Center for Drug Evaluation and Research
`
`
`
`
`ENCLOSURE:
`
`
`
`• Content of Labeling
`
`
`o Prescribing Information
`
`
`
` 5 http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM375154.pdf
`
` 6 http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm090142.htm
`
`
`
`U.S. Food and Drug Administration
`
`
`
`
`
`Silver Spring, MD 20993
`
`www.fda.gov
`
`
`
`Reference ID: 4523408
`
`

`

`Signature Page 1 of 1
`--------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically. Following this are manifestations of any and all
`electronic signatures for this electronic record.
`--------------------------------------------------------------------------------------------
`/s/
`------------------------------------------------------------
`
`ANN T FARRELL
`11/21/2019 05:50:07 PM
`
`Reference ID: 4523408
`
`

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