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Exelixis' cabozantinib NDA for advanced kidney cancer gets Priority Review; PDUFA date June 22

Jan. 28, 2016 10:24 AM ETExelixis, Inc. (EXEL) StockEXELBy: Douglas W. House, SA News Editor1 Comment
  • The FDA grants Priority Review status for Exelixis' (EXEL -2.7%) New Drug Application (NDA) seeking clearance for Breakthrough Therapy- and Fast Track-tagged cabozantinib for the treatment of advanced renal cell carcinoma.
  • Priority Review shortens the agency's review clock to six months from the standard 10 months. Its action date (PDUFA) is June 22.
  • The company's Marketing Authorization Application (MAA) in Europe is currently under accelerated assessment by the EMA, which shortens the review clock to 150 days from the standard 210 days.
  • Cabozantinib is currently marketed as COMETRIQ in the U.S. for the treatment of medullary thyroid cancer. It inhibits the activity of enzymes called tyrosine kinases, which play key roles in the proliferation and survival of cancer cells.
  • Previously: Exelixis finalizes NDA submission for cabozantinib for kidney cancer (Dec. 23, 2015)

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