The preclinical new drug research program of the National Cancer Institute.

The discovery and development of anticancer drugs with clinical potential are the responsibility of the Developmental Therapeutics Program (DTP), Division of Cancer Treatment, National Cancer Institute (NCI). Approximately 10,000 compounds/year are selectively acquired and screened against murine tumor models in order to discover new, active materials. The program required to accomplish this objective, as well as the subsequent tasks of formulation development and toxicology testing, is described. Since its inception in 1955, the preclinical new drug research program of the NCI has played a major role in the discovery and development of new agents which have been entered into clinical trial. The NCI has been responsible for the discovery of eight of the 16 commercially available drugs discovered since 1955. In addition, the NCI has played an important role in the clinical evaluation of all 16 of these New Drug Application (NDA)-approved drugs. During 1977-1982, the NCI filed Investigational New Drug Applications (INDA) for 33 cytotoxic agents. It was responsible for the discovery of the antitumor activity of 73% of these compounds. Most of the INDA compounds were acquired directly through NCI efforts. The DTP active acquisition program was responsible for obtaining 69% of these materials, with an additional 12% coming from the DTP intramural research program. Only 19% were received as voluntary submissions. The DTP active acquisition and screening effort is shown to have played even a larger role in identifying and obtaining those compounds which are currently in earlier stages of the NCI drug discovery and development process.