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C. Oncologic Drugs Advisory Committee Bethesda, Maryland January 31, 2002. C. Introduction. Burkhard Daldrup, PhD Global Head, Drug Regulatory Affairs Oncology Business Unit Novartis Pharmaceuticals Corporation. ZOMETA belongs to a new class of highly potent bisphosphonates

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oncologic drugs advisory committee bethesda maryland january 31 2002

C

Oncologic Drugs Advisory Committee

Bethesda, Maryland

January 31, 2002

introduction

C

Introduction

Burkhard Daldrup, PhDGlobal Head, Drug Regulatory AffairsOncology Business Unit

Novartis Pharmaceuticals Corporation

zometa overview
ZOMETA belongs to a new class of highly potent bisphosphonates

Treatment of hypercalcemia of malignancy

Approved by FDA in August 2001

Approved in over 60 countries

Treatment of bone metastases

Filed July 2001 in EU and August 2001 in US and other major countries

Dose: Zoledronic acid 4 mg infused over 15 min q 3 to 4 wk

Non-oncologic uses under evaluation

Paget’s disease, osteoporosis, rheumatoid arthritis

ZOMETA®Overview
zometa in bone metastases proposed indication
ZOMETA (zoledronic acid) is indicated for the treatment of osteolytic, osteoblastic, and mixed bone metastases of solid tumors and osteolytic lesions of multiple myeloma, in conjunction with standard antineoplastic therapyZOMETA® in Bone Metastases Proposed Indication
zometa in bone metastases phase iii trials
ZOMETA® in Bone MetastasesPhase III Trials

Three randomized, international, parallel, double-blind trials

ZOMETA 4 mg and 8 mg PatientTrial N versus population Duration

010 1,648 Pamidronate Multiple myeloma 13 mo Breast cancer

039 643 Placebo Prostate cancer 15 mo

011 773 Placebo Other solid tumors 9 mo

zometa in bone metastases clinical p rofile 1
ZOMETA is bone specific, not tumor specific; effective in a broad variety of tumor types studied

Breast cancer and multiple myeloma

Prostate and other solid tumors

Other bisphosphonates have not demonstrated efficacy in these tumor types

ZOMETA® in Bone MetastasesClinical Profile (1)
zometa in bone metastases clinical p rofile 2
First bisphosphonate shown to be effective across a wide variety of solid tumor types in treatment of bone metastases

Safety is comparable with that of i.v. pamidronate

Overall safety profile is supported by data from over 3,000 patients treated with ZOMETA

ZOMETA® in Bone MetastasesClinical Profile (2)
agenda
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . Burkhard Daldrup, PhD

Pathophysiology of Metastatic Bone Diseaseand the Role of Bisphosphonates . . . . . . . . . . Prof. Robert Coleman, MD, FRCP

ZOMETA® in Breast Cancer and Multiple Myeloma . . . . . . . . . . . . . . . . . . . . . James Berenson, MD, Paul Gallo, PhD

ZOMETA® in Prostate Cancer and Solid Tumors Other Than Prostate Cancer

and Breast Cancer . . . . . . . . . . . . . . . . . . . . . . . . . Matthew Smith, MD Prof. Robert Coleman,

MD, FRCP

Conclusions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . David Parkinson, MD

Agenda
questions and answers
Novartis Oncology

Clinical Research and Development . . John Seaman, PharmD

Consultants

Statistics . . . . . . . . . . . . . . . . . . . . . . . . . . Richard J. Cook, PhD

Thomas R. Fleming, PhD

Clinical Experts

Lung and Other Cancers . . . . . . . Pierre P. Major, MD, FRCPC

Radiologic Analysis . . . . . . . . . Joseph F. Simeone, MD, FACR

Renal Advisory Board . . . . . . . . . . Raimund R. Hirschberg, MD

Questions and Answers