(Reuters) - Exelixis Inc said preliminary results from a phase III trial show its experimental drug cabozantinib met the main primary goal of improving progression-free survival (PFS) in patients with medullary thyroid cancer.
The median (PFS) was 11.2 months for patients taking cabozantinib versus 4 months for those on placebo (hazard ratio 0.28, p<0.0001).
The ongoing trial, named EXAM, is being conducted under a special protocol assessment (SPA) agreement with the U.S. Food and Drug Administration.
Exelixis said it was requesting permission to begin a rolling submission of the new drug application for cabozantinib in advanced medullary thyroid cancer and expects the filing will be completed in the first half of 2012.
AstraZeneca Plc's vandetanib was approved in April by the U.S. health regulator for treatment of medullary thyroid cancer.
Cabozantinib, which is also being tested for metastatic ovarian cancer and prostate cancer, is an oral drug designed to inhibit MET, RET and vascular endothelial growth factor 2.
In June, the company reported data from a clinical trial showing the drug led to significant tumor shrinkage in several different types of solid tumors, including 24% of patients with metastatic ovarian cancer, but it caused the deaths of six patients.
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