(BUSINESS WIRE)--Exelixis, Inc. (Nasdaq:EXEL) today announced that the U.S. Food & Drug Administration (FDA) has granted orphan drug designation to XL184 for treatment of follicular, medullary, and anaplastic thyroid carcinoma, and metastatic or locally advanced papillary thyroid cancer. A pivotal phase 3 trial of XL184 is ongoing in patients with medullary thyroid cancer (MTC) and the company expects to release top-line phase 3 results in the first-half of 2011 and potentially file a New Drug Application (NDA) for the compound in the second-half of 2011. Exelixis also is evaluating XL184 in phase 2 in solid tumors including metastatic castration-resistant prostate cancer, ovarian cancer, melanoma, breast cancer, non-small cell lung cancer, and hepatocellular cancer, and in a phase 1 trial in renal cell carcinoma and differentiated thyroid cancer. Additionally, a phase 2 trial in recurrent glioblastoma is ongoing.
