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    Uro Pipeline: Supplemental application submitted for advanced RCC treatment

    Supplemental application submitted for advanced RCC treatment


    Exelixis Inc. has completed the submission of a supplemental new drug application to the FDA for cabozantinib (Cabometyx) to treat advanced renal cell carcinoma (RCC). Results from CABOSUN, a randomized phase II trial of cabozantinib in patients with untreated advanced RCC with intermediate- or poor-risk disease, were used in the submission. The CABOSUN trial enrolled 157 patients who were randomized 1:1 to receive either cabozantinib or sunitinb (Sutent) once daily for 4 weeks. The primary endpoint of the trial, which was reached in mid-2016, was to demonstrate a statistically significant improvement of progression-free survival for advanced RCC patients in comparison with sunitinib. Secondary endpoints include overall survival and objective response rate. Cabozantinib was previously approved by the FDA in April 2016 for the treatment of patients with advanced RCC who have received prior anti-angiogenic therapy.

    UTI vaccine receives fast track designation from FDA

    Sequoia Sciences has received fast track designation from the FDA for its investigational vaccine designed to treat recurrent urinary tract infections (UTIs) caused by multidrug-resistant bacteria. The vaccine is designed to trigger an immune response, preventing bacteria from colonizing the urinary tract. In the first clinical trial of the vaccine completed by Sequoia, of the 67 enrolled women, 30 had a 2-year documented history of recurrent UTI. The vaccine was well tolerated and generated a strong immune response, the company reported. Initiation of additional studies is ongoing, including evaluating the vaccine in patients requiring last line of defense antibiotics.

    Next: Prostate Ca screening test focus of prospective U.S. trial

    Ben Schwartz
    Ben Schwartz is Associate Editor, Contemporary OB/GYN.


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