GSK said the FDA accepted for priority review a supplemental Biologics License Application for Jemperli (dostarlimab) in previously untreated stage II/III mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) locally advanced disease. The priority-review acceptance is a near-term regulatory milestone that can improve the likelihood/timing of a potential approval path. No financial figures were provided in the release.
GSK said the FDA accepted for priority review a supplemental Biologics License Application for Jemperli (dostarlimab) in previously untreated stage II/III mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) locally advanced disease. The priority-review acceptance is a near-term regulatory milestone that can improve the likelihood/timing of a potential approval path. No financial figures were provided in the release.
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