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.
Richard Pazdur, MD
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
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 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.
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
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.
The article by Eckardt et al reviews numerous anticancer drugs presently undergoing clinical development in the United States. These drugs have an array of biochemical targets. Some agents, such as the camptothecin analogs, represent a novel class of antineoplastic drugs. Other drugs, such as docetaxel (Taxotere), are analogs of currently available drugs (paclitaxel [Taxol]) [1,2]. Still other agents, such as thymidylate synthase (TS) inhibitors (eg, ZD1694 [Tomudex], AG-331, and LY231514) and 5-ethynyluracil, a uracil reductase inhibitor, have been designed prospectively to inhibit specific enzymatic pathways [3-5]. Some agents discussed have preliminary activity in refractory diseases, such as that of irinotecan (CPT-11) in fluorouracil-refractory colon carcinoma and that of docetaxel in cisplatin (Platinol)-refractory non-small-cell lung carcinoma, or show activity in diseases for which standard therapies are less than optimal.