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FDA Grants Special Protocol Assessment to Phase III Ublituximab/Ibrutinib Study
"TG Therapeutics has reached an agreement with the FDA regarding a Special Protocol Assessment for a phase III clinical trial exploring ublituximab (TG-1101, a chimeric recombinant glycoengineered monoclonal antibody directed against CD20) in combination with ibrutinib (Imbruvica) for the treatment of
Approval of Imbruvica Frontline for 17p deleted CLL and Important Trials
Hi Friends,
The recent approval of ibrutinib for 17p deletion frontline hopefully is the opening wedge of more indications for treatment naive patients for it and other non-chemo choices.
I have posted why this is so important and a list with links to some important clinical trials on my latest blog
Zydelig: The Black Box Warnings for use in CLL
Hi Friends,
On my blog (http://bkoffman.blogspot.com), I have commented on the extensive black box warnings on the label for idelalisib or ZYDELIG that is a stark contrast to no black box for ibrutinib, not that IMBRUVICA doesn't come with its own set of cautions and concerns.