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(Alliance News) - GSK PLC on Tuesday said the European Medicines Agency has validated its marketing authorisation application for its dostarlimab drug, marketed as Jemperli.
The London-based pharmaceutical firm said the authorisation is for Jemperli in combination with chemotherapy for the treatment of adult patients with mismatch repair deficient/microsatellite instability-high primary advanced or recurrent endometrial cancer, a type of gynaecological cancer.
The firm noted the EMA's Committee for Medicinal Products for Human Use will begin a formal review process to a recommend marketing authorisation to the European Commission.
GSK said the application is based on interim results from a phase III trial, which met its primary endpoint of progression-free survival.
The trial showed a "statistically significant and clinically meaningful benefit versus placebo plus chemotherapy in patients treated with dostarlimab plus carboplatin-paclitaxel in the dMMR/MSI-H population," GSK added.
Senior Vice President and Global Head of Oncology Development Hesham Abdullah said: "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 III trial.
"These patients currently face significant unmet medical needs, and this combination could change the treatment paradigm for this condition. The RUBY phase III trial continues to follow patients for the dual-primary endpoint of overall survival in the intent-to-treat population."
The firm expects a US regulatory filing review to take place in the first half of 2023.
GSK shares fell 0.2% to 1,471.80 pence each in London on Tuesday morning.
By Harvey Dorset, Alliance News reporter
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