NDA 21- 174

4/13/00


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Table of Contents

NDA 21- 174

Pharmaceutical Category: Immunotoxin

Gemtuzumab Ozogamicin

Gemtuzumab Ozogamicin

Regulatory Issues: Accelerated Approval

Regulatory Issues: Accelerated Approval

Overview of Review Issues

Studies submitted for Review as of 10/99

Studies Reviewed

INCLUSION AND EXCLUSION CRITERIA

Protocol outline

Primary Endpoints: Safety Complete Response (CR)

“Morphologic Remission” (CRp)

“Morphologic Remission” (CRp)

Efficacy Results: original 104 patients with relapsed AML

Original NDA (N=104) compared with updated efficacy data (N=142)

Original NDA (N=104) compared with updated efficacy data (N=142)

CRp=CR? Relapse-Free Survival

Relapse-Free Survival

Survival data Issues

Prognostic Factors in Relapsed AML

Response Rates vs. Age

Response Rates vs. Age

Response Rates vs. Duration of First Remission

Response Rates vs. Duration of First Remission

Efficacy Conclusions

Safety Issues

Safety: Acute Infusion-Related Events

Safety: Antibodies

Safety: Bleeding and Transfusion Events (per person )

Safety: Bleeding

Safety: Neutropenia, Infections

Safety: GI Toxicity

Safety: Hepatotoxicity

Hepatic Venoocclusive Disease (VOD)

Hepatic Venoocclusive Disease (VOD)

Safety Summary: Advantages

Safety Summary: Disadvantages

Issues to Consider

Regulatory Options:

Review Team

Author: CDER USER