VALCHLORgel0.016%(氮芥外用软有)药品审评(FDA)

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CENTER FOR DRUG EVALUATIONAND

RESEARCH

APPLICATION NUMBER:

202317Orig1s000

MEDICAL REVIEW(S)

CLINICAL REVIEW

Application Type

Application Number(s)

Priority or Standard

Submit Date(s)

Received Date(s)

PDUFA Goal Date

Division/Office

Reviewer Name(s)

Review Completion Date

Established Name

(Proposed)Trade Name

Therapeutic Class

Applicant

Formulation(s)

Dosing Regimen

Indication(s)

Intended Population(s)

NDA 505(b)(2)

202317

Class 2 Resubmission

27 February 2013

27 August 2013

DHP/OHOP

R.Angelo de Claro,M.D.

25 June 2013

Mechlorethamine

Valchlor

Antineoplastic

Ceptaris Therapeutics,Inc.

0.016%gel

Topical,once daily

CTCL Stage IA and IB,

second-line therapy

Adults ≥18 years

Template Version:March 6,2009

Reference ID:3331209

Clinical Review

R. Angelo de Claro , M.D.

NDA 202317

Valchlor ( Mechlorethamine gel)

Table of Contents

1 RECOMMENDATIONS /RISK BENEFIT ASSESSMENT ............................................... 5

1.1 Recommendation on Regulatory Action ......................................................................... 5

1.2 Risk Benefit Assessment ................................................................................................... 5

1.3 Recommendations for Postmarket Risk Evaluation and Mitigation Strategies ... 7

1.4 Recommendations for Postmarket Requirements and Commitment ..................... 7

2 INTRODUCTION AND REGULATORY BACKGROUND ............................................... 7

3 ETHICS AND GOOD CLINICAL PRACTICES ...................................................................

3.1 Submission Quality and Integrity ..................................................................................... 8

3.2 Compliance with Good Clinical Practices....................................................................... 8

3.3 Financial Disclosures........................................................................................................... 8

4 SIGNIFICANT EFFICACY /SAFETY ISSUES RELATED TO OTHER REVIEW

DISCIPLINES ...............................................................................................................................

4.1 Chemistry Manufacturing and Controls.............................................................................

4.2 Clinical Microbiology ...........................................................................................................

4.3 Preclinical Pharmacology /Toxicology............................................................................... 9

4.4 Clinical Pharmacology...........................................................................................................9

5 SOURCES OF CLINICAL DATA ........................................................................................... 9

5.1 Tables of Studies /Clinical Trials ....................................................................................... 9

5.2 Review Strategy ................................................................................................................... 9

5.3 Discussion of Individual Studies /Clinical Trials.............................................................. 9

6 REVIEW OF EFFICACY...............................................................................................................

Efficacy Summary ...........................................................................................................................

7 REVIEW OF SAFETY ............................................................................................................. 10

Safety Summary ........................................................................................................................... 10

7.1 Methods.................................................................................................................................. 11

7.2 Adequacy of Safety Assessments................................................................................... 11

7.3 Major Safety Results ..........................................................................................................11

8 POSTMARKET EXPERIENCE ............................................................................................... 11

9 APPENDICES ........................................................................................................................... 12

9.1 Literature Review /References ....................................................................................... 12

9.2 Labeling Recommendation .............................................................................................. 12

9.3 Advisory Committee Meeting........................................................................................... 13

Reference ID:3331209

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CENTERFORDRUGEVALUATIONANDRESEARCHAPPLICATIONNUMBER:202317Orig1s000MEDICALREVIEW(S)CLINICALREVIEWApplicationTypeApplicationNumber(s)PriorityorStandardSubmitDate(s)ReceivedDate(s)PDUFAGoalDateDivision/OfficeReviewerName(s)ReviewCompletionDateEstablishedName(Proposed)TradeNameTherapeuticClassApplicant...

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