GlaxoSmithKline (GSK)

GSK’s Jemperli Wins Approval for Treating Mismatch Repair-Deficient Tumors

August 20, 2021

The FDA has granted GlaxoSmithKline’s (GSK) monoclonal antibody Jemperli (dostarlimab) an expanded indication for treating adults with mismatch repair-deficient (dMMR) recurrent or advanced solid tumors, usually found in endometrial, colorectal or other gastrointestinal cancers.

GSK could be eyeing Jemperli as a potential blockbuster with multiple indications to compete against Merck’s Keytruda (pembrolizumab), which received FDA approval in 2017 for treating adult and pediatric patients with specific types of dMMR solid tumors.

Jemperli’s new indication, which occurred under the FDA’s controversial accelerated approval pathway, was supported by an open-label study showing nearly 62 percent of patients had a response to therapy with 95 percent of those patients demonstrating a duration of response lasting more than six months, said GSK.

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