ODAC ponders 'accelerated approval'

WASHINGTON - In its review of Alza Corp.'s Doxil liposomal doxorubicin last week, an FDA advisory panel addressed two issues of broad import for the drug approval process: whether off-label uses should be taken into consideration when making decisions about accelerated approvals and misuse by sponsors of the term "accelerated."

The Oncologic Drugs Advisory Committee (ODAC) recommended by a 9-2 vote that the agency provide accelerated approval of Doxil for the treatment of patients with metastatic carcinoma of the ovary who are refractory to both paclitaxal- and platinum-based chemotherapy...