GSK's Rectal Cancer Drug Jemperli Accepted for Priority Review by FDA
By Michael Hennessey
GSK said the U.S. medicines regulator has accepted Jemperli, or dostarlimab, for priority review to treat a subtype of rectal cancer.
The U.K. drugmaker said Monday that the U.S. Food and Drug Administration has set a deadline of February to assess the drug.
The treatment is also eligible for review through the national priority voucher program, which could result in an earlier decision, GSK said.
Jemperli could eliminate the need for chemotherapy, radiation and surgery for some patients, the company said.
Rectal cancer, a type of bowel cancer, affects around 770,000 people globally each year. Between 5% and 10% of cases have the subtype being targeted by Jemperli.
Separately on Monday, GSK said Japan has approved Hibsago as a functional cure for chronic hepatitis B. It is the first global approval for the drug, and is the only functional cure treatment for chronic hepatitis B in Japan, the company said.
Write to Michael Hennessey at michael.hennessey@wsj.com
(END) Dow Jones Newswires
August 24, 2026 02:34 ET (06:34 GMT)
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