FDA grants accelerated approval to dostarlimab for rectal cancer

The FDA granted accelerated approval to dostarlimab for locally advanced rectal cancer, according to an agency notice titled "FDA grants accelerated approval to dostarlimab for locally advanced rectal cancer." The notice was also published under the agency's oncology update feed.¹

A separate FDA press announcement described the decision in more detail. The FDA approved a new use of the immunotherapy Jemperli, known chemically as dostarlimab-gxly, for certain patients with locally advanced rectal cancer, stating that the approval may let some of these patients forgo standard treatments such as chemotherapy, radiation, and surgery, which can carry lasting effects on daily life.²

The documents provided do not include additional details on the clinical trial data, dosing regimen, or specific patient population criteria that supported the approval. As with other accelerated approvals, continued marketing for this use may depend on verification of clinical benefit in further studies, though the documents do not specify confirmatory trial requirements for this particular approval.