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Biotech / Medical : Exelixis, Inc. (EXEL)
EXEL 46.52-0.2%Dec 24 12:59 PM EST

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From: Ian@SI10/6/2015 3:12:00 AM
   of 930
 
I hadn't realized that the decision was only 5 weeks away.

Roche says data shows Cotellic combination therapy effective

Thomson Reuters

ZURICH, Oct 6 (Reuters) - Swiss drugmaker Roche
said final survival data from a Phase III clinical trial showed
the Cotellic drug used in combination with Zelboraf helped
people with previously untreated BRAF V600 mutation-positive
advanced melanoma live significantly longer compared to Zelboraf
alone.



Ongoing monitoring did not identify any new safety signals.
Long-term safety data was expected later this year, it added in
a statement on Tuesday. Cotellic was discovered by Exelixis Inc
and is being developed by Roche and Exelixis.


Last month, an EU advisory panel recommended Cotellic in
combination with Zelboraf. A decision by the European Commission
is expected by the end of 2015. A decision from the U.S. Food
and Drug Administration (FDA) on Roche's new drug application is
expected by Nov. 11, it said.
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