FDA clears Jemperli alone for some rectal cancers

The US Food and Drug Administration on Monday granted accelerated approval to Jemperli (dostarlimab-gxly), made by GlaxoSmithKline, for use on its own in adults with previously untreated stage II or stage III locally advanced rectal cancer whose tumours are mismatch repair deficient or microsatellite instability-high, as shown by an FDA-authorised test. The agency said published estimates put that group at about 3 percent of locally advanced rectal cancers, and that it completed the review nearly four months ahead of schedule under Priority Review.

The decision rests on interim results from AZUR-1, a phase 2 study in 154 patients who received up to nine doses over six months: after a median follow-up of more than two years, almost three quarters had not needed surgery, radiotherapy or chemotherapy. Because the approval is accelerated, GSK must continue following patients to confirm that the responses produce lasting benefit, and the FDA said longer follow-up is still needed on how long responses last and how often the cancer returns.