Ibrutinib, Obinutuzumab Are Early Tests Of How Fast Breakthrough Reviews Will Be
This article was originally published in Pharmaceutical Approvals Monthly
Ibrutinib application is among the first for a breakthrough therapy designee and should provide an early indicator of FDA review expectations for the newest expedited approval program.
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FDA’s much-anticipated guidance on expedited programs for drug development fills in some blanks on the new breakthrough designation, but simply advising sponsors they will need to pick up the pace on manufacturing plans and development of companion diagnostics leaves aspiring applicants wanting more, stakeholders said at DIA.
Companies receiving breakthrough designations seem just as unclear as investors about the value of the program.
The agency needs more experience making the decisions before it lays out the evidence threshold for a breakthrough designation, CDER Director Janet Woodcock says.