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US FDA grants "breakthrough" status for Janssen and Pharmacyclics ibrutinib – The Pharma Letter

February 14, 2013Monoclonal Anti-CD20 Antibodiesadmin

US FDA grants "breakthrough" status for Janssen and Pharmacyclics ibrutinib
The Pharma Letter
A Phase III randomized, multi-center registration trial of ibrutinib as a monotherapy versus temsirolimus in relapsed or refractory MCL patients who received at least one prior rituximab-containing chemotherapy regimen, RAY (MCL3001). • A Phase III ...

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