GSK plans to submit AMCR batch alignments for Jemperli in dMMR/MSI-H rectal cancer worldwide in 2026, emphasizing a synthetic review of its global clinical data and real-world evidence. This aligns with the AZUR-1 trial's interim results showing sustained clinical complete responses supporting Jemperli as a potential first-line immunotherapy option. The submissions aim to support accelerated and full approvals globally, with a focus on eliminating chemotherapy, radiation, and surgery for some patients. Recent positive CHMP opinion and FDA Fast Track designation support this pathway.
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