Cancellation of Late Cycle Review Meeting, October 17, 2014 - TRUMENBA

DATE: October 17, 2014

FROM: 

Marion. F. Gruber, PhD., Director
Office of Vaccines Research & Review
Center for Biologics Evaluation and Research (CBER)
Food and Drug Administration (FDA)

TO: Biologics License Application Submission Tracking Number # 125549/0

PRODUCT: Trumenba, Meningococcal group B vaccine

SUBJECT: Pfizer’s request for cancellation of Late Cycle Review Meeting

THROUGH: 

Drusilla Burns, PhD. 
Chair, STN 125549/0 BLA Review Committee 
DBPAP, OVRR

CC: Michael Smith

APPLICANT: Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc.

This serogroup B meningococcal vaccine was designated breakthrough therapy and the STN 125549/0 BLA was given “priority review.” Because of the public health importance of this vaccine, CBER worked closely with the applicant to be able to complete the review of this BLA in an expedited manner.

Pfizer has responded to all information requests from CBER regarding this BLA, those issues have been resolved, and there are no other major outstanding review issues. During the mid-cycle meeting on October 9, 2014, the applicant was informed that CBER has not identified any additional issues and/or safety concerns that would affect the completion of the review of this BLA.

In an e-mail sent to me on October 16, 2014, Donna Boyce of Pfizer noted that a) only final label negotiations that are expected to be completed within the week of October 20, 2014, and b) submission of lot release testing for the (b)(4) launch lots that are scheduled for submission October 24, 2014, remain. Thus, Pfizer requested that the proposed December 11, 2014, Late Cycle Review meeting be cancelled.   I informed Pfizer on October 17, 2014, per e-mail, that CBER will cancel the Late-Cycle Review Meeting.

See e-mail chain below on this matter:





From: Gruber, Marion 
Sent: Friday, October 17, 2014 11:14 AM
To: Boyce, Donna
Cc: Burns, Drusilla L.; Smith, Michael (CBER)
Subject: RE: Trumenba BLA

Dear Donna,

I herewith confirm that CBER will cancel the Late Cycle Review Meeting since there are no major outstanding issues with STN 125549/0.

Marion Gruber

Marion Gruber, PhD
Director,
Office of Vaccines Research & Review
Center for Biologics Evaluation & Research
Food & Drug Administration, DHHS
10903 New Hampshire Ave.
Building 71, Rm 3230
Silver Spring, MD 20993-0002

Tel.:  (301) 796 1856
Fax.: (301) 595 1124

E-mail: marion.gruber@fda.hhs.gov

From: Boyce, Donna [mailto:Donna.Boyce@pfizer.com] 
Sent: Thursday, October 16, 2014 5:54 PM
To: Gruber, Marion
Subject: Trumenba BLA

Dear Marion,

During the October 9, 2014 mid-cycle review meeting, CBER communicated to Pfizer that the review of the  Trumenba BLA was nearing completion and that CBER had not identified any issues or safety concerns that would affect approval of the BLA.  Moreover, Pfizer’s responses to all CBER  Information Requests have been submitted.  Only final label negotiations (expected be completed within the next week) and submission of lot release testing for the (b)(4) launch lots (scheduled for submission October 24, 2014)  remain.  Therefore, Pfizer respectfully requests that the proposed December 11, 2014 Late Cycle Review meeting be cancelled.   Please contact me with any questions.

Sincerely,
Donna

Donna Boyce
Vice President
Global Regulatory Affairs, Vaccines
Worldwide Safety & Regulatory
Pfizer. Inc.
Office-484-865-5035
Mobile- ----(b)(6)--------
