`
` NDA 203341/S-020
`
`
`
`SUPPLEMENT APPROVAL/
`FULFILLMENT OF POSTMARKETING
` REQUIREMENT
`
`
`PF Prism C.V.
`c/o Pfizer Inc.
`Attention: Aparna Srirangam, MS, PhD
`Senior Manager, Pfizer Global Regulatory Affairs
`10646 Science Center Drive
`San Diego, CA 92121
`
`
`Dear Dr. Srirangam:
`
`Please refer to your supplemental new drug application (sNDA) dated November 24,
`2020, received November 24, 2020, and your amendments, submitted under section
`505(b) of the Federal Food, Drug, and Cosmetic Act (FDCA) for BOSULIF (bosutinib)
`tablets.
`
`This Prior Approval supplemental new drug application provides for regular approval of
`
`the treatment of adult patients with newly diagnosed Philadelphia chromosome positive
`(Ph+) Chronic phase (CP), chronic myelogenous leukemia (CML) indication. In addition,
`this supplement provides updates to the United States Prescribing Information (USPI) in
`the Adverse Reactions, Warnings and Precautions, Nonclinical Toxicology, Clinical
`Studies, and Patient Labeling sections based upon results from the BFORE trial (Study
`1053).
`
`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.
`
`
`WAIVER OF ½ PAGE LENGTH REQUIREMENT FOR HIGHLIGHTS
`
`Please note that we have previously granted a waiver of the requirements of 21 CFR
`201.57(d)(8) regarding the length of Highlights of Prescribing Information.
`
`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 Food and Drug Administration (FDA) automated drug registration and listing system
`
`Reference ID: 4795961
`
`
`
`NDA 203341/S-020
`Page 2
`
`
`(eLIST), as described at FDA.gov.1 Content of labeling must be identical to the enclosed
`labeling (text for the Prescribing Information, Patient Package Insert), 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.
`
`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).
`
`SUBPART H FULFILLED
`
`We approved NDA 203341 supplement 009 under the regulations at 21 CFR 314
`Subpart H for accelerated approval of new drugs for serious or life-threatening illnesses.
`Approval of this supplement fulfills your requirement made under 21 CFR 314.510.
`
`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
`the claimed indication in pediatric patients unless this requirement is waived, deferred,
`or inapplicable.
`
`Because this drug product for this indication has an orphan drug designation, you are
`exempt from this requirement.
`
`
`
`
`
`
`
` 1 http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm
`
`
`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: 4795961
`
`
`
`NDA 203341/S-020
`Page 3
`
`
`FULFILLMENT OF POSTMARKETING REQUIREMENTS
`
`We have received your submission dated November 24, 2020, containing the final
`report for the following postmarketing requirement listed in the December 19, 2017
`supplement approval letter.
`
`
`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.
`
`
`We have reviewed your submission and conclude that the above requirement was
`fulfilled.
`
`This completes all of your postmarketing requirements acknowledged in our December
`19, 2017, supplement approval letter.
`
`PROMOTIONAL MATERIALS
`
`You may request advisory comments on proposed introductory advertising and
`promotional labeling. For information about submitting promotional materials, see the
`final guidance for industry Providing Regulatory Submissions in Electronic and Non-
`Electronic Format-Promotional Labeling and Advertising Materials for Human
`
`Prescription Drugs.3
`
`You must submit final promotional materials and Prescribing Information, accompanied
`by a Form FDA 2253, at the time of initial dissemination or publication
`[21 CFR 314.81(b)(3)(i)]. Form FDA 2253 is available at FDA.gov.4 Information and
`
` Instructions for completing the form can be found at FDA.gov.5
`
`All promotional materials that include representations about your drug product must be
`promptly revised to be consistent with the labeling changes approved in this
`supplement, including any new safety information [21 CFR 314.70(a)(4)]. The revisions
`in your promotional materials should include prominent disclosure of the important new
`safety information that appears in the revised labeling. Within 7 days of receipt of this
`letter, submit your statement of intent to comply with 21 CFR 314.70(a)(4).
`
`REPORTING REQUIREMENTS
`
`
`We remind you that you must comply with reporting requirements for an approved NDA
`(21 CFR 314.80 and 314.81).
`
`
`
`
`
` 3 For the most recent version of a guidance, check the FDA guidance web page at
`https://www.fda.gov/media/128163/download.
`4 http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM083570.pdf
`
`
`5 http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM375154.pdf
`
`
`U.S. Food and Drug Administration
`
`
`Silver Spring, MD 20993
`www.fda.gov
`
`
`
`Reference ID: 4795961
`
`
`
`NDA 203341/S-020
`Page 4
`
`
`If you have any questions, contact Brad McKenzie, Regulatory Project Manager, at
`
`bradley.mckenzie@fda.hhs.gov or (301) 876-1463.
`
`
`
`Sincerely,
`
`{See appended electronic signature page}
`
`
`R. Angelo de Claro, MD
`Division Director
`Division of Hematologic Malignancies I
`Office of Oncologic Diseases
`Center for Drug Evaluation and Research
`
`
`ENCLOSURE(S):
` Content of Labeling
`
`o Prescribing Information
`
`o Patient Package Insert
`
`
`
`
`
`
`U.S. Food and Drug Administration
`
`
`Silver Spring, MD 20993
`www.fda.gov
`
`Reference ID: 4795961
`
`
`
`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/
`------------------------------------------------------------
`
`ROMEO A DE CLARO
`05/14/2021 02:40:28 PM
`
`Reference ID: 4795961
`
`(
`
`
`
`
Accessing this document will incur an additional charge of $.
After purchase, you can access this document again without charge.
Accept $ ChargeStill Working On It
This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.
Give it another minute or two to complete, and then try the refresh button.
A few More Minutes ... Still Working
It can take up to 5 minutes for us to download a document if the court servers are running slowly.
Thank you for your continued patience.
This document could not be displayed.
We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.
Your account does not support viewing this document.
You need a Paid Account to view this document. Click here to change your account type.
Your account does not support viewing this document.
Set your membership
status to view this document.
With a Docket Alarm membership, you'll
get a whole lot more, including:
- Up-to-date information for this case.
- Email alerts whenever there is an update.
- Full text search for other cases.
- Get email alerts whenever a new case matches your search.
One Moment Please
The filing “” is large (MB) and is being downloaded.
Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.
Your document is on its way!
If you do not receive the document in five minutes, contact support at support@docketalarm.com.
Sealed Document
We are unable to display this document, it may be under a court ordered seal.
If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.
Access Government Site