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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
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`NDA 203341/S-009
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`Food and Drug Administration
`Silver Spring MD 20993
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`ACCELERATED APPROVAL
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`PF Prism C.V.
`c/o Pfizer Inc.
`Attention: Bhanu Purohit, MS
`Global Regulatory Lead, Worldwide Safety and Regulatory
`445 Eastern Point Road
`MS 8260-1118
`Groton, CT 06340
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`Dear Ms. Purohit:
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`Please refer to your Supplemental New Drug Application (sNDA) dated June 26, 2017, received
`June 26, 2017, and your amendments, submitted under section 505(b) of the Federal Food, Drug,
`and Cosmetic Act (FDCA) for Bosulif (bosutinib) tablets, 100 mg, 400 mg, and 500 mg.
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`This Prior Approval supplemental new drug application provides for a new indication for the
`treatment of adult patients with newly-diagnosed chronic phase (CP) Philadelphia chromosome-
`positive chronic myelogenous leukemia (Ph+ CML).
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`APPROVAL & LABELING
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`We have completed our review of this supplemental application, as amended. It is approved,
`effective on the date of this letter, for use as recommended in the enclosed, agreed-upon labeling
`text.
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`WAIVER OF HIGHLIGHTS SECTION
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`We are waiving the requirements of 21 CFR 201.57(d)(8) regarding the length of Highlights of
`prescribing information. This waiver applies to all future supplements containing revised
`labeling unless we notify you otherwise.
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`CONTENT OF LABELING
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`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
`http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm. Content
`of labeling must be identical to the enclosed labeling (text for the package insert, text for the
`patient package insert), with the addition of any labeling changes in pending “Changes Being
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`Reference ID: 4197387
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`NDA 203341/S-009
`Page 2
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`Effected” (CBE) supplements, as well as annual reportable changes not included in the enclosed
`labeling.
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`Information on submitting SPL files using eList may be found in the guidance for industry titled
`“SPL Standard for Content of Labeling Technical Qs and As” at
`http://www.fda.gov/downloads/DrugsGuidanceComplianceRegulatoryInformation/Guidances/U
`CM072392.pdf.
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`The SPL will be accessible from publicly available labeling repositories.
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`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 MS Word format, that includes the
`changes approved in this supplemental application, as well as annual reportable changes and
`annotate each change. To facilitate review of your submission, 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).
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`ACCELERATED APPROVAL REQUIREMENTS
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`Products approved under the accelerated approval regulations, 21 CFR 314.510, require further
`adequate and well-controlled studies/clinical trials to verify and describe clinical benefit. You
`are required to conduct such studies/clinical trials with due diligence. If postmarketing
`studies/clinical trials fail to verify clinical benefit or are not conducted with due diligence, we
`may, following a hearing in accordance with 21 CFR 314.530, withdraw this approval. We
`remind you of your postmarketing requirement specified in your submission dated
`December 8, 2017. This requirement, along with required completion dates, is listed below.
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`PMR 3317-1 Submit a report of the BFORE trial with 60 months of follow-up data. Datasets
`for efficacy and safety should accompany the report.
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`Trial Completion:
`Final Report Submission:
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`04/2020
`11/2020
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`Submit clinical protocols to your IND 121569 for this product. In addition, under
`21 CFR 314.81(b)(2)(vii) and 314.81(b)(2)(viii) you should include a status summary of each
`requirement in your annual report to this NDA. The status summary should include expected
`summary completion and final report submission dates, any changes in plans since the last
`annual report, and, for clinical studies/trials, number of patients entered into each study/trial.
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`Submit final reports to this NDA as a supplemental application. For administrative purposes, all
`submissions relating to this postmarketing requirement must be clearly designated “Subpart H
`Postmarketing Requirement(s).”
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`Reference ID: 4197387
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`NDA 203341/S-009
`Page 3
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`REQUIRED PEDIATRIC ASSESSMENTS
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`Under the Pediatric Research Equity Act (PREA) (21 U.S.C. 355c), all applications for new
`active ingredients, 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 the claimed indication(s) in pediatric patients unless this requirement is waived,
`deferred, or inapplicable.
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`Because this drug product for this indication has an orphan drug designation, you are exempt
`from this requirement.
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`PROMOTIONAL MATERIALS
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`Under 21 CFR 314.550, you are required to submit, during the application pre-approval review
`period, all promotional materials, including promotional labeling and advertisements, that you
`intend to use in the first 120 days following marketing approval (i.e., your launch campaign). If
`you have not already met this requirement, you must immediately contact the Office of
`Prescription Drug Promotion (OPDP) at (301) 796-1200. Please ask to speak to a regulatory
`project manager or the appropriate reviewer to discuss this issue.
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`As further required by 21 CFR 314.550, submit all promotional materials that you intend to use
`after the 120 days following marketing approval (i.e., your post-launch materials) at least 30
`days before the intended time of initial dissemination of labeling or initial publication of the
`advertisement. We ask that each submission include a detailed cover letter together with three
`copies each of the promotional materials, annotated references, and approved package insert
`(PI)/Medication Guide/patient PI (as applicable).
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`Send each submission directly to:
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`OPDP Regulatory Project Manager
`Food and Drug Administration
`Center for Drug Evaluation and Research
`Office of Prescription Drug Promotions (OPDP)
`5901-B Ammendale Road
`Beltsville, MD 20705-1266
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`Alternatively, you may submit promotional materials for accelerated approval products
`electronically in eCTD format. For more information about submitting promotional materials in
`eCTD format, see the draft Guidance for Industry (available at:
`http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/U
`CM443702.pdf ).
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`REPORTING REQUIREMENTS
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`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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`Reference ID: 4197387
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`NDA 203341/S-009
`Page 4
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`If you have any questions, call Wanda Nguyen, Regulatory Project Manager, at (301) 796-2808.
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`Sincerely,
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`{See appended electronic signature page}
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`Albert Deisseroth, MD, PhD
`Supervisory Associate Division Director
`Division of Hematology Products
`Office of Hematology and Oncology Products
`Center for Drug Evaluation and Research
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`ENCLOSURE:
`Content of Labeling
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`Reference ID: 4197387
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`---------------------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically and this page is the manifestation of the electronic
`signature.
`---------------------------------------------------------------------------------------------------------
`/s/
`----------------------------------------------------
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`ALBERT B DEISSEROTH
`12/19/2017
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`Reference ID: 4197387
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`(
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