Exelixis announced that the FDA has accepted for filing the company’s supplemental new drug application, or sNDA, for Cabometyx tablets as a treatment for patients with previously treated advanced hepatocellular carcinoma, or HCC. The FDA has completed its filing review and has determined that the application is sufficiently complete to permit a substantive review. The filing has been assigned a Prescription Drug User Fee Act, or PDUFA, action date of January 14, 2019. Exelixis announced they submitted the sNDA for the treatment of previously treated advanced HCC to the FDA in March 2018 based on results from the CELESTIAL phase 3 pivotal trial of Cabometyx in patients with advanced HCC who received prior sorafenib.
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