Pfizer gets Sutent, Exubera approvals

On Thursday, FDA approved PFE's Sutent sunitinib for two cancers, and Europe approved Exubera inhaled insulin to treat Type I and Type II diabetes. Exubera is under FDA review with a PDUFA date at the end of this month.

Sutent received regular approval as a second-line treatment for gastrointestinal stromal tumors (GIST) and accelerated approval as a first-line treatment for advanced renal cell carcinoma (RCC). The approval for GIST was based on a Phase III study that was stopped seven months ahead of schedule, when an interim analysis showed the drug significantly prolonged time to progression (TTP). ...