GSK receives FDA approval for Jemperli (dostarlimab-gxly) under the Commissioner’s National Priority Voucher pilot program

The U.S. Food and Drug Administration today granted accelerated approval to Jemperli (dostarlimab-gxly) for dMMR/MSI-H locally advanced rectal cancer, potentially allowing certain patients to avoid chemotherapy, radiation and surgery.

Jemperli is approved as a standalone treatment for adults with previously untreated stage II or III locally advanced rectal cancer whose tumors are mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H). This approval was awarded to GSK, and marks the eleventh approval under the Commissioner’s National Priority Voucher pilot program.

‍

Source: Press Release