FDA Gives OK to Seven New Cancer Drugs in 1997

Publication
Article
Oncology NEWS InternationalOncology NEWS International Vol 7 No 3
Volume 7
Issue 3

ROCKVILLE, Md--The Food and Drug Administration approved 121 new original drugs in 1997 and 431 generic products. Median approval time for new original drugs was shortened by 6%, falling from 15.4 months in 1996 to 14.4 months in 1997.

ROCKVILLE, Md--The Food and Drug Administration approved 121 new original drugs in 1997 and 431 generic products. Median approval time for new original drugs was shortened by 6%, falling from 15.4 months in 1996 to 14.4 months in 1997.

The new entities approved included seven cancer drugs:

  • Fareston (toremifene citrate, Schering-Plough), a once-daily oral antiestrogen, for the first-line treatment of metastatic breast cancer in postmenopausal women with estrogen-receptor-positive or receptor-unknown tumors.
  • Femara (letrozole tablets, Novartis Pharmaceuticals Corporation), a once-daily aromatase inhibitor, for use in the treatment of postmenopausal women with advanced breast cancer that has progressed following the use of antiestrogen therapy.
  • Rituxan (rituximab, IDEC/Genen-tech), the first monoclonal antibody approved for the treatment of cancer in the United States, is a single-agent treatment for follicular, CD-positive, B-cell non-Hodgkin’s lymphoma. Rituxan is given in four infusions over 22 days.
  • Neumega (rhIL-11, American Home Products/Genetics Institute), the first biologic approved that promotes platelet production in patients with solid tumors or lymphoma who are undergoing chemotherapy.
  • Quadramet (samarium Sm 153 lexidronam injection, Cytogen), a radiopharmaceutical for the amelioration of pain from cancers that have metastasized to bone. The agent can be administered as a single intravenous injection on an outpatient basis.
  • Anzemet (dolasetron mesylate, Hoechst Marion Roussel), a selective
  • 5-HT3 receptor antagonist for the prevention of nausea and vomiting in chemotherapy and surgery patients.
  • Sclerosol Intrapleural Aerosol (sterile talc powder, Sciarra Laboratories) to treat malignant pleural effusions.

Newsletter

Stay up to date on recent advances in the multidisciplinary approach to cancer.

Recent Videos
4 experts in this video
4 experts in this video
Those being treated for peritoneal carcinomatosis may not have to experience the complication rates or prolonged recovery associated with surgical options.
For patients with peritoneal carcinomatosis, integrating PIPAC into a treatment regimen does not interrupt their systemic therapy.
2 experts in this video