[Expanded access program in the United States and Alimta program for malignant mesothelioma patients].
In the United States, Expanded Access Program is allowed by FDA to facilitate the availability of promising new drugs to desperately ill patients as early in the drug development process as possible, before marketing begins, and to obtain additional data on the drug's safety and effectiveness. Eli Lilly conducted Alimta Expanded Access Programs for 1200 malignant mesothelioma patients with free of charge and obtained clinical efficacy and severe adverse events. The system development for Expanded Access Program should be discussed for future Japanese participation to this program.
Nambu
Yoshihiro
Y
Oncology and Cardiovascular Products, Lilly Research Laboratories Japan.
D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D002986:Clinical Trials as Topic / Q000379:methods; D017277:Drug Approval; D005971:Glutamates / Q000009:adverse effects / Q000627:therapeutic use*; D006147:Guanine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D006801:Humans; D008654:Mesothelioma / Q000188:drug therapy*; D000068437:Pemetrexed; D010997:Pleural Neoplasms / Q000188:drug therapy*; D014481:United States; D014486:United States Food and Drug Administration
D000970:Antineoplastic Agents; D005971:Glutamates; D000068437:Pemetrexed; D006147:Guanine