Even though it says the regulatory timetable for cabozantinib
in metastatic prostate cancer hasn't changed, Exelixis
Inc. is paying a heavy price for news that spooked investors the day
after Halloween.
Based on feedback from FDA in
August, Exelixis thought it was in agreement with the agency about the design
of a Phase III trial intended to show cabozantinib (XL184) can reduce bone pain
in patients with metastatic prostate cancer. But sometime in October, according
to the company, the agency reversed its position on the trial's endpoints.