Exelixis Inc. completed its submission of a supplemental new drug application (sNDA) for US FDA accelerated approval of Cabometyx (cabozantinib) in previously untreated advanced renal cell carcinoma (RCC) on Aug. 16, a day after the drug's competitive position was bolstered by disappointing interim Phase III results for Bristol-Myers Squibb Co.'s Opdivo (nivolumab) and Yervoy (ipilimumab).
South San Francisco-based Exelixis is seeking early approval for its tyrosine kinase inhibitor (TKI) – which blocks MET, AXL and VEGF receptors – based on progression-free survival (PFS) results versus Pfizer Inc.'s Sutent (sunitinib) in the Phase II CABOSUN clinical trial. The difference in median PFS between the trial's two arms was statistically significant, whereas Bristol-Myers reported on Aug
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