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FDA puts GSK's Jemperli on priority review in locally advanced rectal cancer

Published

25 August 2026

Topic

opportunities

Sectors

Biotech

Geography

United States

Source

Read at allsci.com

Verified

Fusion42 · 26 August 2026 · Fusion42 review

The US FDA has accepted for priority review GSK's supplemental Biologics License Application for dostarlimab (Jemperli) to treat previously untreated stage II and III dMMR/MSI-H locally advanced rectal cancer, with a PDUFA date set for February 2027.

This Wire brief sits within Fusion42's coverage of Biotech, and 4 sources have reported it between 24 Aug 2026 and 25 Aug 2026.

◆ The Wire takeaway

You have a new pathway opening in cancer treatment regulations that could dramatically reduce reliance on chemo and surgery for rectal cancer patients. This is your moment to advance immunotherapy options beyond existing standards and carve out new market leadership.

Coverage

4 sources · first reported 24 Aug 2026 · latest 25 Aug 2026

Related on Wire

Topics

BiotechFDApriority-reviewimmunotherapyrectal-cancerGSKdostarlimab