EMA validates marketing authorisation application for Jemperli with chemotherapy
pharmafile | April 25, 2023 | News story | Medical Communications |
GSK has announced that the European Medicines Agency (EMA) has validated the company’s Type II Variation for a new indication for Jemperli (dostarlimab) alongside chemotherapy for the treatment of adult patients with mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) primary advanced or recurrent endometrial cancer.
The EMA’s Committee for Medicinal Products for Human Use (CHMP) is expected to soon begin the formal review process and make its recommendation to the European Commission (EC) surrounding the marketing authorisation for the drug’s new indication.
This submission follows interim results from the RUBY/ENGOT-EN6/GOG3031/NSGO phase 3 trial, which met its primary endpoint of investigator-assessed progression-free survival (PFS), and showed a statistically significant and clinically meaningful benefit when compared to placebo plus chemotherapy. The safety and tolerability of the drug was consistent with its known profile.
The company is expecting regulatory filing based on these results within the first half of 2023.
Hesham Abdullah, senior vice president and global head of Oncology Development at GSK, commented: “New treatment options are urgently needed for patients with primary advanced or recurrent endometrial cancer. With this initial filing, we are accelerating the submission of a potential new indication for dostarlimab in the patient population that demonstrated the strongest treatment effect in the RUBY phase 3 trial. These patients currently face significant unmet medical needs, and this combination could change the treatment paradigm for this condition. The RUBY phase 3 trial continues to follow patients for the dual-primary endpoint of overall survival in the intent-to-treat population.”
Betsy Goodfellow
