Results showed comparable clinical results with significantly fewer side effects in Daunoxome recipients. This drug may take on special significance because it is easily given by primary care providers who are generally reluctant to become involved in cancer chemotherapy. A full profile on this drug is provided elsewhere in the Moore News. The relative merits of rifabutin and clarithromycin for MAC prophylaxis are reviewed elsewhere in this issue of Moore News. Ritonavir is the only protease inhibitor to date that has demonstrable efficacy in a controlled trial with clinical endpoints.
Traditional approval means standard acceptance and no further clinical studies are required.
Accelerated approval means provisional approval usually based on surrogate marker data with traditional approval contingent on the demonstration of clinical benefit in at least two separate studies within two years. The antiviral effect persisted throughout the one year study. Based on these and other surrogate marker studies, indinavir received accelerated approvals. An unusual and celebrated feature of these approvals was the speed with which they occurred. For indinavir, the time from submission to approval was 29 days, which represents an FDA record.