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Jemperli (dostarlimab) accepted for priority review by the US FDA for dMMR/MSI-H locally ...

Published

24 August 2026

Topic

opportunities

Sectors

Biotech

Geography

United States

Source

Read at gsk.com

Verified

Fusion42 · 24 August 2026 · Fusion42 review

The US FDA has accepted for priority review the supplemental Biologics License Application for Jemperli (dostarlimab) to treat dMMR/MSI-H locally advanced rectal cancer, with a PDUFA date in February 2027. Jemperli has the potential to reduce or eliminate the need for chemotherapy, radiation, and surgery for some patients, based on positive phase II trial data.

This Wire brief sits within Fusion42's coverage of Biotech, and 3 sources have reported it.

◆ The Wire takeaway

You can prepare for earlier market access shifts in immunotherapy for rectal cancer as the FDA prioritises Jemperli's review. Competing founders should reassess their differentiation and timing in advanced colorectal treatments.

Coverage

3 sources · 24 Aug 2026

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Topics

Biotechus-fdapriority-reviewimmunotherapyrectal-cancerdmmr-msi-h