GSK's Jemperli wins accelerated FDA approval in rectal cancer

What happened?

1. The FDA granted accelerated approval on Monday to GSK's dostarlimab (Jemperli) for previously untreated, locally advanced rectal cancer in patients with dMMR/MSI-H tumors (MedPage Today; Oncology Nursing News)
2. The indication covers stage II/III disease in a subgroup MedPage Today describes as about 3% of all locally advanced rectal cancers
3. Chemotherapy, radiation and surgery are the standard approach for operable rectal cancer.
4. Support came from the AZUR-1 trial, in which a majority of dMMR/MSI-H rectal cancer and other solid tumor patients given dostarlimab had a complete response and avoided surgery
5. Angelo de Claro, MD, director of the FDA's Oncology Center of Excellence, called the approval an option that avoids surgery, radiation and chemotherapy in this tumor type

GSK's PD-1 inhibitor dostarlimab received accelerated FDA approval in previously untreated, locally advanced rectal cancer for patients with dMMR/MSI-H tumors, according to MedPage Today and Fierce Pharma. The decision rests on the AZUR-1 trial, which reports a high complete response rate, with most treated patients avoiding surgery.

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