Exelixis, FDA Agree on Special Protocol Assessment

Exelixis and the FDA have reached agreement on the registration trial of XL184, a small molecule anti-cancer compound, as part of the Special Protocol Assessment process.

This summer, the company plans to initiate a randomized, placebo-controlled, double-blinded Phase III study of the drug as single-agent therapy in 315 patients with unresectable, locally advanced or metastatic medullary thyroid cancer.

The primary endpoint will be duration of progression-free survival, Exelixis said.