pharmaphorum August 2, 2024
The FDA has cleared GSK’s PD-1 inhibitor Jemperli as a treatment for all adult patients with primary advanced or recurrent endometrial cancer, a key part of the company’s growth ambitions for the drug.
The approval is based on the RUBY trial, which showed that Jemperli (dostarlimab) given with carboplatin and paclitaxel chemotherapy achieved a 31% reduction in the risk of death compared to chemo alone after two and a half years.
Jemperli is the only immuno-oncology agent to demonstrate a survival benefit in this patient population, according to GSK, and is a key approval for the drug as it fends off a challenge in endometrial cancer from MSD’s rival PD-1 inhibitor Keytruda (pembrolizumab).
Jemperli was the first drug in the...
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