`
`
`CENTER FOR DRUG EVALUATION AND
`RESEARCH
`
`
`APPLICATION NUMBER:
`201023s000
`
`MICROBIOLOGY REVIEW(S)
`
`
`
`
`
`
`
`
`
`
`Product Quality Microbiology Review
`
`08-JUN-2010
`
`
`
`NDA 201023/N-000
`
`Drug Product Name
`Jevtana®
`Proprietary:
`Non-proprietary: Cabazitaxel
`
`Assigned to Reviewer
`N/A
`N/A
`N/A
`16-MAR-2010
`
`
`Review Number: 1
`
`Dates of Submission(s) Covered by this Review
`Submit
`Received
`Review Request
`08-JUN-2010
`08-JUN-2010
`N/A
`25-MAY-2010
`25-MAY-2010
`N/A
`21-MAY-2010
`21-MAY-2010
`N/A
`24-FEB-2010
`24-FEB-2010
`15-MAR-2010
`
`
`Applicant/Sponsor
`Name:
`Sanofi Aventis
`Address:
`55 Corporate Drive
`Bridgewater, NJ 08807
`
`Representative: Linda Gustavson, Ph.D.
`Telephone:
`908-304-6221
`
`
`Name of Reviewer: Steven Fong, Ph.D.
`
`Conclusion: CMC-Microbiology recommends APPROVE.
`
`
`
`
`NDA 201-023/N-000
`
`Microbiology Review #1
`
`Product Quality Microbiology Data Sheet
`
`A.
`
`1.
`
`2.
`
`TYPE OF SUBNIISSION: Original NDA.
`
`SUBMISSION PROVIDES FOR: New drug product.
`
`MANUFACTURING SITE:
`
`Aventis Pharma, Dagenham
`Rainham Road South
`
`Dagenham, Essex RM 107XS
`United Kingdom
`
`DOSAGE FORM, ROUTE OF ADMINISTRATION AND
`STRENGTH/POTENCY:
`
`0 Intravenous solution for infilsion.
`
`0 Provided as a kit containing two vials:
`’P Cabazitaxel concentrate for solution for infusion (CCSI),
`60 mg/ l .5 mL.
`F Cabazitaxel solvent (CS), 5.7 mL 13% w/w alcohol. The volume
`includes a
`(mo overfill. Only
`mm is used for dilution of
`CC SI.
`
`0
`
`M4) from the CS vial is mixed with the CCSI vial contents to form a
`
`10 mg/mL intermediate premix.
`0 Premix is diluted with 0.9% sodium chloride or 5% dextrose in an
`
`infusion bag.
`
`METHOD(S) OF STERILIZATION:
`0 CCSI is sterilized by
`M0.
`0 CS is sterilized by
`
`00(4)
`
`6.
`
`PHARMACOLOGICAL CATEGORY: Prostate cancer therapeutic.
`
`B.
`
`C.
`
`SUPPORTING/RELATED DOCUNIENTS: None.
`
`REMARKS:
`
`0 The application was provided in a rolling submission format. The original
`submission was submitted 18-DEC-2009 and contained non-clinical
`
`information only. CMC information was submitted 24-FEB-2010 (amendment
`1, supporting document 2) in eCTD format.
`
`0 The application proposes a promising therapy for metastatic prostate cancer.
`On 09-Nov-2009 the submission was granted Fast Track status.
`
`0 On ll-MAY-2010 an IR was submitted requesting details regarding the
`bacterial ingress test used to assess container—closure integrity, and the method
`
`Page 2 of 30
`
`
`
`NDA 201-023/N-000
`
`Microbiology Review #1
`
`(m4) of the rubber stoppers used for
`and method validation for
`product closure. An amendment response (sponsor submission 14) was
`received on 21-MAY—2010.
`
`0 On 18-MAY-2010 a second IR was submitted requesting information
`regarding the
`m“), the endotoxin
`testing method, the environmental monitoring action limits, and
`(mo
`validation. An amendment response (sponsor submission 17) was
`received on 25-MAY—2010.
`
`0 On 04-JUN-2010 the reviewer placed a phone call to Sanofi-Aventis regulatory
`affairs representative Linda Gustavson regarding the stability data presented in
`support of the proposed CCSI shelf life. On the same day a return phone call
`was received from Sanofi-Aventis regulatory affairs CMC specialist Zareen
`Ahmed clarifying that the information was present in CCSI submission section
`3.2.P.8.3, Table l.
`
`0 On 07-JUN-2010 an IR was sent to the sponsor requesting data supporting the
`proposed
`(m4).
`On 08—JUN—2010 an amendment response was received that contained the
`requested data.
`
`0 The application presented the manufacturing information for CCSI and CS in
`two separate sections. In this review these are referred to, respectively, as the
`CC SI and the CS submission sections.
`
`filename: N201023r1.doc
`
`Page 3 of 30
`
`
`
`NDA 201-023/N—000
`
`Microbiology Review #1
`
`Executive Summary
`
`I.
`
`Recommendations
`
`A.
`
`Recommendation on Approvability — Recommended for
`approval from a microbiology quality standpoint.
`
`B.
`
`Recommendations on Phase 4 Commitments and/or
`
`Agreements, if Approvable — N/A
`
`11.
`
`Summary of Microbiology Assessments
`
`A.
`
`B.
`
`C.
`
`Brief Description of the Manufacturing Processes that relate to
`Product Quality Microbiology - CCSI is
`M0
`15 mL glass vials that are
`rubber stoppers and aluminum(m4)
`
`sealed with 13 mm grey (mo
`overseals. CS is
`
`filled into the same container—closure system used for CCSI: 15
`mL glass vials sealed with 13 mm grey (m4) rubber stoppers and
`aluminum overseals. The CS vials are
`(no)
`
`Brief Description of Microbiology Deficiencies — No deficiencies
`identified.
`
`Assessment of Risk Due to Microbiology Deficiencies - 1VIinimal
`risk.
`
`III.
`
`Administrative
`
`A.
`
`Reviewer’s Signature
`Steven Fong, Ph.D., Microbiology Reviewer
`
`B.
`
`Endorsement Block
`
`C.
`
`CC Block N/A
`
`Bryan Riley, Ph.D.
`Senior Microbiology Reviewer
`
`26 Pages Have Been Withheld In Full As b4(CCI/TS) Immediately Following This Page
`
`Page 4 of 30
`
`
`
`Application
`Type/Number
`--------------------
`NDA-201023
`
`Submission
`Type/Number
`--------------------
`ORIG-1
`
`Submitter Name
`
`Product Name
`
`--------------------
`SANOFI AVENTIS
`SPA
`
`------------------------------------------
`CABAZITAXEL (XRP6258)
`
`---------------------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically and this page is the manifestation of the electronic
`signature.
`---------------------------------------------------------------------------------------------------------
`/s/
`----------------------------------------------------
`
`STEVEN E FONG
`06/08/2010
`Recommended for approval from a microbiology quality standpoint.
`
`BRYAN S RILEY
`06/08/2010
`I concur.
`
`
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