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news.Exelixis received orphan drug designation from the US Food and Drug Administration (FDA) for XL184 for the treatment of follicular, medullary, and anaplastic thyroid carcinoma, and metastatic or locally advanced papillary thyroid cancer.
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A pivotal phase III trial of XL184 in patients medullary thyroid cancer (MTC) in currently being conducted.
Exelixis expects to release top-line phase III results in the first-half of 2011 and file a new drug application (NDA) for the compound in the second-half of 2011.
The company is evaluating XL184 in a phase II trial in patients with solid tumours including metastatic castration-resistant prostate cancer, ovarian cancer, melanoma, breast cancer, non-small cell lung cancer, and hepatocellular cancer.
The company is also evaluating XL184 in a Phase 1 trial in renal cell carcinoma and differentiated thyroid cancer, and in a Phase II trial in XL184 in recurrent glioblastoma.
FDA grants orphan drug designation to those drugs that treat diseases that affect fewer than 200,000 people in the US.
Cabozantinib is an inhibitor of tumour growth, metastasis, and angiogenesis, which simultaneously targets MET and VEGFR2, key kinases involved in the development and progression of many cancers.