Sorting out the meaning of 'commitment'

When the FDA's Oncologic Drugs Advisory Committee voted against approval of DepoTech Corp.'s DepoCyt sustained release formulation of cytarabine last December, the company did not cry foul. But it clearly felt that both FDA and ODAC had signed off in 1992 on the trial design that the panel was now saying was inadequate (see BioCentury Extra, Dec. 19, 1997).

Still, there was hope that FDA would act within its prerogatives and ignore the panel's recommendation by approving DepoCyt for neoplastic meningitis associated with solid tumors. That didn't happen, as the FDA last week sent DEPO a non-approvable letter stating that the NDA does not contain adequate information for approval and that evidence of patient benefit was not persuasive...