New Drug Application Filing for Ibrutinib Acce... - CLL Support

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New Drug Application Filing for Ibrutinib Accepted in Two B-cell Malignancies by the U.S. FDA

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This is NOT an approval, it is the beginning of the approval process but only for two uses or indications... previously treated mantle cell lymphoma (MCL) and previously treated chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL).

online.wsj.com/article/PR-C...

Another step forward in the approval process...

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