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tasigna approved, page-3

  1. 61 Posts.
    Malmanu, I asked for well researched thoughts...do your homework! Everyone knows tasigna (nilotonib) is a second line therapy for CML - I was asking for thoughts (well researched) now that TASIGNA (NILOTONIB) is a FIRST LINE THERAPY and the impact this will have on Omapro given that the CML treatment landscape is clearly changing...CXS are hoping to get approval for Gleevec resistance CML patients, not Tasigna resistant CML patients. What does this mean for the CXS?

    June 17, 2010; FDA approves Tasigna for first-line Ph+ CML
    FDA granted accelerated approval to Tasigna nilotinib from Novartis AG (NYSE:NVS; SIX:NOVN) for first-line treatment of Philadelphia chromosome-positive (Ph+) chronic myelogenous leukemia (CML) in chronic phase. As part of the approval, Novartis is required to collect additional long-term efficacy and safety data. The BCR-ABL tyrosine kinase inhibitor already is approved as second-line treatment for chronic and accelerated phase Ph+ CML, including patients who are resistant to the company's Gleevec imatinib.
    The approval was based on data from the Phase III ENESTnd trial, in which Tasigna met the primary endpoint of a significantly higher rate of major molecular response vs. Gleevec imatinib at 12 months
 
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