FDA has approved Jemperli from GSK (NYSE:GSK) for adult patients with mismatch repair-deficient or advanced endometrial carcinoma (dMMR).
GSK predicts Jemperli will generate peak sales of $1.4 billion to $2.8 million.
The drug is indicated for adults with dMMR-related or advanced endometrial carcinoma who have progressed after a previous platinum-containing regimen. This drug is not suitable for those who need curative surgery or radiation.
Approved based on a Phase 1 studyThe FDA approved the drug based on data from GARNET Phase 1, in which it had a 45.4% overall response rate. The single-arm, multicenter, open-label study of Jemperli monotherapy showed that 85.9% of patients experienced a response within 12 months. 54.7% had a response lasting at least 24 months.
Data from the ongoing GARNET trial’s A1 cohort supported Jemperli’s approval. This trial evaluated Jemperli as a monotherapy in patients with advanced solid tumors. The dru…