FDA’s Pazdur and Blumenthal: the march of checkpoint inhibitors will continue


21 February 2017 - More approvals of new immune-checkpoint inhibitors, targeted and personalised therapies, as well as the use of real-world evidence are coming in the near future, Richard Pazdur, director of the Office of Haematology and Oncology at the US FDA\ and associate director Gideon Blumenthal wrote in a comment published this week in Nature.

Those expectations follow 2016 oncology approvals for FDA that included five new molecular entities and 17 efficacy supplements, including six accelerated approvals, 17 priority reviews and 11 approvals of breakthrough-designated therapies. FDA also approved five companion diagnostics, including a liquid biopsy test to assist in patient selection. And one new anti-PD-L1 antibody was approved, along with six supplementary approvals of anti-PD-1/PD-L1 antibodies.

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Michael Wonder

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Michael Wonder