CENTER FOR DRUG EVALUATION AND
RESEARCH
APPLICATION NUMBER:

205755Orig1s000
STATISTICAL REVIEW(S)

 DEPARTMENT OF HEALTH AND HUMAN SERVICES

?6 Public Health Service

an Food and Drug Administration
Center for Drug Evaluation and Research

Memorandum

 

Date: March 25, 2014
From: Karen Boyd, M.S., 

Subject: Statistics primary and secondary review

 

The Statistics primary and secondary review was combined with the clinical primary and
secondary review, signed 3/25/14.

STATISTICS FILING CHECKLIST FOR A NEW NDA/BLA
NDA Number: 205755

Applicant: Novartis Pharmaceuticals
Corporations

Drug Name: Ceritinib

NDA/BLA Type: NME

Stamp Date: 12/24/2013

On initial overview of the NDA/BLA application for RTF:

Content Parameter

Yes

1

Index is sufficient to locate necessary reports, tables, data,
etc.

X

2

ISS, ISE, and complete study reports are available
(including original protocols, subsequent amendments, etc.)

X

3

Safety and efficacy were investigated for gender, racial,
and geriatric subgroups investigated (if applicable).

X

4

Data sets in EDR are accessible and do they conform to
applicable guidances (e.g., existence of define.pdf file for
data sets).

X

No

NA

Comments

SCE replaced ISE.

IS THE STATISTICAL SECTION OF THE APPLICATION FILEABLE? Yes
If the NDA/BLA is not fileable from the statistical perspective, state the reasons and provide
comments to be sent to the Applicant.
Please identify and list any potential review issues to be forwarded to the Applicant for the 74day letter.

Content Parameter (possible review concerns for 74day letter)

Yes

Designs utilized are appropriate for the indications requested.

X

Endpoints and methods of analysis are specified in the
protocols/statistical analysis plans.
Interim analyses (if present) were pre-specified in the protocol
and appropriate adjustments in significance level made.
DSMB meeting minutes and data are available.
Appropriate references for novel statistical methodology (if
present) are included.

X

Safety data organized to permit analyses across clinical trials
in the NDA/BLA.
Investigation of effect of dropouts on statistical analyses as
described by applicant appears adequate.

X

Reference ID: 3439315

No

NA

X
X

X

Comment

 --------------------------------------------------------------------------------------------------------This is a representation of an electronic record that was signed
electronically and this page is the manifestation of the electronic
signature.
--------------------------------------------------------------------------------------------------------/s/
---------------------------------------------------LIJUN ZHANG
01/21/2014
SHENGHUI TANG
01/21/2014

Reference ID: 3439315