Richard Pazdur, MD | Authors

Preface

March 25, 2011

Preface

Eltrombopag for the Treatment of Chronic Immune (Idiopathic) Thrombocytopenic Purpura

December 01, 2009

On November 20, 2008, the US Food and Drug Administration (FDA) granted accelerated approval for eltrombopag (Promacta Tablets, GlaxoSmithKline) for the treatment of thrombocytopenia in patients with chronic immune thrombocytopenic purpura (ITP) who have had an insufficient response to corticosteroids, immunoglobulin therapy, or splenectomy.

Romiplostim for the Treatment of Chronic Immune (Idiopathic) Thrombocytopenic Purpura

July 14, 2009

On August 22, 2008, the US Food and Drug Administration (FDA) granted marketing approval (licensure) to romiplostim (Nplate, Amgen Inc) for the treatment of thrombocytopenia in patients with chronic immune (idiopathic) thrombocytopenic purpura (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy.

Erlotinib/Gemcitabine for First-Line Treatment of Locally Advanced or Metastatic Adenocarcinoma of the Pancreas

December 01, 2007

Erlotinib (Tarceva) is a human epidermal growth factor receptor type 1/epidermal growth factor receptor (HER1/EGFR) tyrosine kinase inhibitor initially approved by the US Food and Drug Administration for the treatment of patients with locally advanced or metastatic non–small-cell lung cancer after failure of at least one prior chemotherapy regimen. In this report, we present the pivotal study that led to the approval of erlotinib in combination with gemcitabine (Gemzar) in patients with locally advanced/metastatic chemonaive pancreatic cancer patients. The combination demonstrated a statistically significant increase in overall survival accompanied by an increase in toxicity. Physicians and patients now have a new option for the treatment of locally advanced/metastatic adenocarcinoma of the pancreas.

Liposomal Doxorubicin in Combination With Bortezomib for Relapsed or Refractory Multiple Myeloma

November 01, 2007

Liposomal doxorubicin received FDA approval for use in combination with bortezomib in patients with multiple myeloma who have not previously received bortezomib and have received at least one prior therapy.

Cancer Management: A Multidisciplinary Approach

June 01, 2007

The fundamental principle behind this book, as stated by the publisher, The Oncology Group (also publisher of the journal ONCOLOGY and news magazine Oncology News International) was to provide a truly integrated, multidisciplinary approach to the management of cancer patients. For this updated 10th edition, the editors have enlisted 114 medical, surgical, and radiation oncologists, whose contributions provide an excellent overview of the important principles of cancer management.

Deferasirox for the Treatment of Chronic Iron Overload in Transfusional Hemosiderosis

December 01, 2006

This report describes the Food and Drug Administration's review of data and analyses leading to the approval of the oral iron chelator, deferasirox for the treatment of chronic iron overload due to transfusional hemosiderosis.

Topotecan in Combination With Cisplatin for the Treatment of Stage IVB, Recurrent, or Persistent Cervical Cancer

October 01, 2006

Topotecan, a camptothecin analog previously approved for the treatment of ovarian cancer and small-cell lung cancer, was granted regular approval by the US Food and Drug Administration (FDA) on June 14, 2006, for use in combination with cisplatin to treat women with stage IVB, recurrent, or persistent carcinoma of the cervix not amenable to curative treatment with surgery and/or radiation therapy. The purpose of this summary is to review the database supporting this approval.

PROs: Defining Clinical Benefit From the Patient's Perspective

May 01, 2006

Drugs approved by the US Food and Drug Administration (FDA) must demonstrate substantial evidence of efficacy from adequate and well-controlled trials and be safe for their intended use. A 1962 amendment to that Act codifies the efficacy requirement. Guidance promulgated in the 1980s indicated that efficacy should represent a "clinical benefit" demonstrated by prolongation of life, better life, or effect on an established surrogate for at least one of these. Direct clinical benefit assessments have included improvements in survival, physical functioning, or tumor-related symptoms.

Colorectal Cancer: Diagnosis and Management

April 01, 2005

In the United States, cancer of the large bowel is the second most common cause of cancer deaths after cancer of the lung [1]. 1995 estimates place large bowel cancer as the third most common malignancy, behind lung and prostate carcinomas in men and behind lung and breast cancers in women.