GSK PLC (LSE:GSK, NYSE:GSK) said the European Commission had granted marketing authorization for Jemperli (dostarlimab) in combination with chemotherapy for the treatment of advanced or recurrent endometrial cancer.
This approval positions Jemperli as the first frontline immuno-oncology treatment in the European Union specifically for patients with mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) primary advanced or recurrent endometrial cancer.
The approval is based on the results of the RUBY/ENGOT phase III trial, which demonstrated a significant improvement in progression-free survival (PFS) for patients treated with Jemperli plus carboplatin and paclitaxel, compared to chemotherapy alone.
"People living with this type of endometrial cancer typically experience disease progression and poor long-term outcomes with the current standard of care," said Hesham Abdullah, GKS's global head of oncology research.
"With this approval, we can expand the number of patients who can potentially benefit from treatment with Jemperli in Europe, including patients who are earlier in their journey."
Endometrial cancer is a form of the disease that originates in the endometrium, the lining of the uterus (womb). It is most commonly found in women who have gone through menopause, but it can occur at any age.
It is considered the sixth most common cancer in women worldwide, with over 400,000 new cases reported per year