A small, private affair

In 2004, Gloucester Pharmaceuticals Inc. took a bet on a small molecule HDAC inhibitor that Fujisawa Co. Ltd. was divesting. That bet looks to have paid off, as FDA's the Oncologic Drugs Advisory Committee last week recommended approval of Istodax romidepsin to treat cutaneous T cell lymphoma.

ODAC voted 10-0 with one abstention that Istodax romidepsin has a favorable risk/benefit profile in patients with cutaneous T cell lymphoma (CTCL), based on impressive duration of response data from two single-arm Phase II trials (see Cover Story)...