尼拉帕尼（nirapatib)胶囊的审评（CDER）非临床_毒理_临床药理_临床和统计.pdf

CENTERFORDRUGEVALUATIONAND

RESEARCH

APPLICATIONNUMBER:

208447Orig1s000

MULTI-DISCIPLINEREVIEW

ExecutiveSummary

NonclinicalPharmacology/Toxicology

ClinicalPharmacology

StatisticalandClinicalEvaluation

NDA/BLA

Multi‐disciplinary

Review

and

Evaluation

Application

Type

New

Drug

Application

Application

Number(s)

208447

Priority

or

Standard

Priority

Submit

Date(s)

10/31/2016

Received

Date(s)

10/31/2016

PDUFA

Goal

Date

6/30/2017

Division/Office

Division

of

Oncology

Products

1/Office

of

Hematology

and

Oncology

Products

Review

Completion

Date

3/22/2017

Established

Name

Niraparib

(Proposed)

Trade

Name

Zejula™

Pharmacologic

Class

Poly(ADP‐ribose)

polymerase

(PARP)

inhibitor

Code

name

MK‐4827

Applicant

TESARO

INC

Formulation(s)

Capsules:

100

mg

Dosing

Regimen

300

mg

(three

100

mg

capsules)

taken

orally

once

daily

Applicant

Proposed

ZEJULA™

is

a

poly(ADP‐ribose)

polymerase

(PARP)

(b)(4)

inhibitor

Indication(s)/Population(s)

indicated

for

the

maintenance

treatment

of

adult

patients

with

platinum‐sensitive

recurrent

epithelial

ovarian,

fallopian

tube,

or

primary

peritoneal

cancer

who

are

in

response

to

platinum‐based