Genentech has joined the 'inner circle of checkpoint inhibitor developers' with the approval of Tecentriq - a PD-L1 drug for bladder cancer. The rarefied inner circle includes BMS and Merck with Opdivo and Keytruda. The approval of Tecentriq is based on a Phase II trial following positive results from a single arm study involving 310 patients.
According to Clinical Trials the Phase 11 trial had a Estimated Study Completion Date of August 2017. The FDA granted an accelerated approval highlighting the intense interest by the regulatory body in advancing promising immunotherapy drugs. Just to spell it out - that's Phase 11 not a Phase 111 pivotal trial.
Meanwhile back in Australia, Imugene has announced that it has received Institutional Review Board approval for the HER-Vaxx Phase 1b/2 clinical study in gastric cancer. The Estimated Study Completion Date is September 2018 but things can move surprisingly quicker if the results are promising.
How quick was that
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