FOOD AND DRUG ADMINISTRATION
Center for Drug Evaluation and Research
Oncologic Drugs
Advisory Committee
Slides
Presented
The
committee will discuss the results of a confirmatory trial for NDA 21-399,
IRESSA® (gefitinib) AstraZeneca PharmaceuticalsLP, for the treatment of
patients with locally advanced or metastatic non-small cell lung cancer after
failure of both platinum-based and docetaxel chemotherapies.
Astra
Zeneca L.P.
Introduction
& Regulatory History Mark
Scott, Ph.D.
Trial
709 Kevin
Carroll, MSc
Clinical
Actions and Implications Judith
Ochs, M.D.
Summary Mark Scott, Ph.D.
Supporting
Slides
Open
Public Hearing Speakers
Committee
Discussion
The
committee will discuss safety concerns, specifically osteonecrosis of the jaw
(ONJ), associated with two bisphosphonates, NDA 21-223, ZOMETA® (zoledronic
acid) Injection and AREDIA®, NDA 20-036 (pamidronate disodium for injection),
both from Novartis Pharmaceuticals Corp.
Zometa is indicated for the treatment of patients with Multiple Myeloma
and patients with documented bone metastases from solid tumors, in conjunction
with standard antineoplastic therapy.
Prostate cancer should have progressed with at least one hormonal therapy. It is also approved for hypercalcemia of
malignancy. AREDIA is indicated, in
conjunction with standard antineoplastic therapy, for the treatment of
osteolytic bone metastases of breast cancer and osteolytic lesions of multiple
myeloma. It is also indicated for the
treatment of moderate or severe hypercalcemia associated with malignancy, and
treatment of patients with moderate to severe Paget’s disease of bone.
FDA Presentation
Regulatory
History of Zometa & Aredia Nancy Scher, M.D., Medical Officer
[HTML] [PPT] Division of Oncology Drug Products,
FDA
Post-Marketing
Safety Assessment of Carol Pamer, R.Ph.
Osteonecrosis
of the Jaw: Pamidronate and Office
of Drug Safety, FDA
Zoledronic
Acid
Osteonecrosis
of the Jaws in Myeloma: Brian Durie, M.D.
Time
Dependent Correlation with Zometa & Hematology/Oncology
Zometa
Use
Novartis Pharmaceuticals
Presentation
ONJ
Reported in Bisphosphonates Treated Diane Young, M.D.
Patients
– An Overview Vice
President & Global Head
[HTML] [PPT] Clinical
Development - Oncology
Clinical
Benefit of Bisphosphonates in Cancer James Berenson, M.D.
Patients
with Metastatic Bone Disease Director, Multiple Myeloma and Bone
Metastases Programs
[HTML] [PPT]
Supporting
Slides
Open
Public Hearing Speakers
Felice
O’Ryan
Kaiser
Permanente
Committee
Discussion