The committee will discuss investigational new drug application (IND) 157775, for dostarlimab for injection, submitted by GlaxoSmithKline LLC. The proposed indication (use) for this product is for monotherapy in patients with mismatch repair deficiency/microsatellite instability-high (dMMR/MSI-H) locally advanced rectal cancer (LARC). FDA would like to obtain the committee’s input on the following: (1) the adequacy of the proposed trial(s) to evaluate the benefits and risks of dostarlimab for the proposed indication, including trial design, study population, clinical endpoint, and patient follow-up; and (2) the adequacy of the proposed data package to permit an assessment of the benefits and risks of dostarlimab for the proposed indication.

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