Cancer Drug Gets Priority FDA Review After Trial Shows No Signs of Tumors
FDA grants priority review to Jemperli after a trial shows yearlong disappearance of rectal tumors.
GSK's cancer drug Jemperli has received priority review from the U.S. Food and Drug Administration (FDA) following a trial that showed no signs of rectal tumors for at least a year in a large percentage of patients. This could potentially change how certain rectal cancers are treated and allow some patients to avoid chemotherapy, radiation, and surgery.
The FDA has given the application a February 2027 deadline, but an earlier decision is possible due to the National Priority Voucher program and Project Orbis. The trial, known as AZUR-1, involves 154 patients who received nine cycles of Jemperli over six months. The drug demonstrated a significant improvement in clinical complete responses lasting for 12 months compared to the existing standard of care.
Jemperli could become the first immunotherapy capable of eliminating or delaying the need for traditional treatments, which often lead to long-term negative quality of life impacts and complications.
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