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    Uro Pipeline: FDA accepts two supplemental applications for mUC agent


    Phase II data suggest drug’s efficacy in bladder, prostate Ca

    Two phase II studies demonstrated that apatorsen improved outcomes in bladder and prostate cancer patients when administered in combination with docetaxel and abiraterone acetate (Zytiga). OncoGenex Pharmaceuticals announced the results at the Genitourinary Cancers Symposium in Orlando, FL. The Borealis-2 trial evaluated apatorsen in combination with docetaxel treatment in 200 metastatic bladder cancer patients who did not respond to platinum-based chemotherapy. Patients who received the combination treatment experienced a 20% reduction in risk of death and also saw higher response durations compared to those receiving docetaxel alone. The Pacific trial evaluated the ability of apatorsen, in combination with abiraterone, to reverse or delay treatment resistance in 72 men whose PSA rose when taking abiraterone acetate alone. The primary endpoint assessed the percentage of patients who were progression free at study day 60 using the combination therapy compared to abiraterone on its own. In men receiving the combination therapy, 33% were progression free at the endpoint compared to 17% receiving abiraterone alone.


    FDA accepts biologics license application for mUC treatment

    The FDA has accepted for priority review EMD Serono’s Biologics License Application for avelumab as a treatment for metastatic urothelial carcinoma. Avelumab has been given a Prescription Drug User Fee Act target action date of August 27, 2017. The Priority Review status reduces the review time from 10 months to 6 months from the day of filing. The drug is an investigational, fully human anti-PD-L1 antibody and has been involved in at least 30 international clinical programs, including nine phase III trials. Avelumab received priority review status in November 2016 for the treatment of metastatic Merkel cell carcinoma.

    Next: Combination RCC treatment yields positive phase II results

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


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