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  • 10/2/19 1:15 pm PDT

    Interim data from the Phase II CONTROL Trial showed that the addition of prophylactic treatment with loperamide plus budesonide reduced the rate of discontinuation due to neratinib-associated diarrhea to 11% versus a discontinuation rate of 18% with loperamide alone.

    LOS ANGELES--(BUSINESS WIRE)--Puma Biotechnology, Inc. (NASDAQ: PBYI) announced that the U.S. Food and Drug Administration (FDA) has approved a labeling supplement for NERLYNX® (neratinib) for the extended adjuvant treatment of HER2-positive early stage breast cancer. With the approval of the labeling supplement, the label now includes safety information based on interim results from Puma’s Phase II CONTROL Trial, a study evaluating antidiarrheal prophylaxis or dose escalation in the reductionmore...

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Puma Biotechnology, Inc.
10880 Wilshire Blvd., Suite 2150
Los Angeles, CA 90024
424-248-6500 Main
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ir@pumabiotechnology.com