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Old 04-05-2012, 12:45 PM   #5
Rich66
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Re: Roche to file T-DM1 breast cancer drug on good data

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The positive results from the first Phase III trial of the medicine - dubbed T-DM1 - clears the way for it to be submitted to European and U.S. authorities for approval this year,

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In a brief statement on Friday, Roche revealed only that patients on T-DM1 lived "significantly longer" without their disease progressing.

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Analyst hopes for T-DM1 have been running high, following earlier good results in Phase II tests, and a filing of the product with regulators this year had been widely expected on the back of data from the so-called EMILIA clinical trial.
Roche said the EMILIA progression-free survival data would be presented at an upcoming medical meeting, adding that final results for overall survival were not yet mature.
Kaemmerer of WestLB believes the full set of results for progression-free survival are likely to be presented at the June 1-5 annual meeting of the American Society of Clinical Oncology, with overall survival results becoming available by 2014.
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