SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Exelixis, Inc. (Nasdaq:EXEL) today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the company’s supplemental New Drug Application (sNDA) for CABOMETYX® (cabozantinib) tablets as a treatment for patients with previously treated advanced hepatocellular carcinoma (HCC). The FDA has completed its filing review …
Tag Archives: Cabometyx
May, 2018
December, 2017
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20 December
FDA Expands Approval of Exelixis’ Cabometyx for Previously Untreated Advanced Renal Cell Carcinoma
SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Exelixis, Inc. (NASDAQ:EXEL) today announced that the U.S. Food and Drug Administration (FDA) approved CABOMETYX® (cabozantinib) tablets for the expanded indication of patients with advanced renal cell carcinoma (RCC). RCC is the most common form of kidney cancer in adults. The FDA’s priority review and approval of CABOMETYX …
August, 2017
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16 August
Exelixis Submits sNDA for Cabometyx for the Treatment of Previously Untreated Advanced Kidney Cancer
SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Exelixis, Inc. (NASDAQ:EXEL) today announced it has completed the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for CABOMETYX®(cabozantinib) tablets as a treatment for patients with previously untreated advanced renal cell carcinoma (RCC). The sNDA submission is based on …
February, 2017
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27 February
Bristol-Myers Squibb and Exelixis Partner for Late-Stage Combination Trial in First-Line Renal Cell Carcinoma
SOUTH SAN FRANCISCO, Calif. & NEW YORK–(BUSINESS WIRE)–Exelixis, Inc. (Nasdaq:EXEL) and Bristol-Myers Squibb Company (NYSE:BMY) today announced the companies have entered into a clinical development collaboration to evaluate CABOMETYX™ (cabozantinib), Exelixis’ small molecule inhibitor of receptor tyrosine kinases, with Opdivo (nivolumab), Bristol-Myers Squibb’s PD-1 immune checkpoint inhibitor, either alone or …
April, 2016
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26 April
Exelixis’ Renal Cell Carcinoma Drug Receives FDA Approval
SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Exelixis, Inc. (NASDAQ:EXEL) today announced that the U.S. Food and Drug Administration (FDA) has approved CABOMETYX™ (cabozantinib) tablets for the treatment of patients with advanced renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy. RCC is the most common form of kidney cancer in adults. …