Global status of clinical photodynamic therapy: the registration process for a new therapy.
The clinical use of photodynamic therapy (PDT) has been ongoing for over a decade. However, attempts to apply for approval of the therapy from boards of health for general use began only in 1989. The unique nature of PDT and the resultant changes in the normal drug registration process, as well as steps which are being taken to approve PDT for the treatment of endobronchial lung cancer, superficial bladder cancer and esophageal cancer are described. The current clinical status of PDT in these indications is also reviewed.
Marcus
S L
SL
Medical Research Division, Lederle Laboratories (a Division of American Cyanamid Co.), Pearl River, New York 10965.
Dugan
M H
MH
D000970:Antineoplastic Agents / Q000627:therapeutic use*; D004938:Esophageal Neoplasms / Q000188:drug therapy*; D017324:Hematoporphyrin Derivative; D006415:Hematoporphyrins / Q000627:therapeutic use*; D006801:Humans; D007880:Legislation, Drug; D008175:Lung Neoplasms / Q000188:drug therapy*; D010778:Photochemotherapy; D011838:Radiation-Sensitizing Agents / Q000627:therapeutic use*; D001749:Urinary Bladder Neoplasms / Q000188:drug therapy*
D000970:Antineoplastic Agents; D006415:Hematoporphyrins; D011838:Radiation-Sensitizing Agents; D017324:Hematoporphyrin Derivative