Oncologic Drugs Advisory
Committee
Slides
The
committee will discuss New Drug Application (NDA) 21-491, proposed trade name
Xinlay™(astrasentan hydrochloride) capsules, Abbott Laboratories, proposed
indication for the treatment of men with metastatic hormone-refractory prostate
cancer.
. Sponsor Presentation Abbott
Laboratories
Introduction Gary
Gordon, M.D.
Oncology
Vice President
Unmet Need & Mechanistic Rationale Joel B. Nelson, M.D.,
Chairman of Urology
Efficacy Darryl
J. Sleep, M.D., FCS
Oncology
Global Project Head
Safety Gary
Gordon, M.D.
Places in Therapy Howard Scher, M.D.
Chief
of Genitourinary Oncology
Supporting Slides
FDA Presentation
Xinlay (atrasentan) FDA Review Amna Ibrahim, M.D.
Medical Officer, Division of
Drug Oncology Products, FDA
and
Shenghui
Tang Ph.D.
Statistical Reviewer, Division
of Drug Oncology Products, FDA
Ralph B. D’Agostino, Ph.D.
Open Public Hearing Speakers
Questions
to the Committee
September
13, 2005 PM Sexxion
The committee will discuss NDA 21-743, S003, Tarceva ™(erlotinib)
Tablets, OSI Pharmaceuticals, Inc, proposed indication for the first line
treatment, in combination with gemcitabine, of patients with locally advanced,
unresectable or metastatic pancreatic cancer.
Sponsor
Presentation
Tarceva (erlotinib)
Tablets Pablo J. Cagnoni, MD
Pancreatic Cancer Vice
President Medical Affairs & Translational Research
OSI
Pharmaceuticals, Inc.
Background of Pancreatic
Cancer & Malcolm Moore, MD
NCIC PA.3 Study Design Professor of Medicine and
Pharmacology
Chair, NCIC Clinical Trials
Group—GI Committee
Clinical Efficacy Data Gary M. Clark, PhD
Review of Study NCIC PA.3 Vice President
Biostatistics and Data Management
OSI Pharmaceuticals, Inc.
Clinical Safety Data
Review of Study NCIC PA.3 Vice President Drug Safety
and Medical Writing
OSI Pharmaceuticals, Inc.
Tarceva® (erlotinib)
Tablets Mace Rothenberg, MD
Concluding Remarks and
Risk/Benefit Summary Associate Professor of
Medical Oncology
Vanderbilt University
FDA
Presentation
Tarceva (erlotinib) FDA
review Adrian
Senderowicz, M.D.
Medical
Officer, Division of Drug Oncology Products, FDA
Open Public Hearing Speakers
Questions to the Committee