US FDA Advisory Committee votes in support of trials designed to evaluate Jemperli as a potential treatment for MMR-D/MSI-high locally advanced rectal cancer
Hesham Abdullah, Senior Vice President, Global Head of Oncology Development, GSK, said: “The Committee’s positive vote in favour of our proposed clinical trial programme for dostarlimab reinforces our plans to generate data in support of a future US regulatory submission for the potential treatment of patients with dMMR/MSI-H locally advanced rectal cancer, a patient population with significant unmet medical needs and a standard of care that results in serious quality of life concerns. We thank the committee for the constructive dialogue and we look forward to continued interactions with FDA as we progress our development programme.”
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