The US Food and Drug Administration (FDA) has accepted GSK’s supplemental biologics licence application (sBLA) for its Jemperli (dostarlimab) plus chemotherapy for priority review.
The company is seeking approval for the combination therapy to treat mismatch repair deficient/microsatellite instability-high primary advanced or recurrent endometrial cancer in adult patients.
The regulatory body aims to take a decision on the application by 23 September 2023 under the Prescription Drug User Fee Act.
Jemperli is a programmed death receptor-1 (PD-1)-blocking monoclonal antibody belonging to a class of drugs that bind to the PD-1 receptor and block it from interacting with the PD-1 ligands PD-L1 and PD-L2.
The therapy recently received breakthrough therapy designation for this new indication.
The sBLA submitted to the FDA was based on the pre-specified interim analysis data obtained from part one of the Phase III RUBY/ENGOT-EN6/GOG3031/NSGO trial conducted in primary advanced or recurrent endometrial cancer patients.
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Part one was designed to assess dostarlimab in combination with carboplatin-paclitaxel, followed by dostarlimab against carboplatin-paclitaxel along with placebo followed by placebo.
The findings showed that patients treated with dostarlimab plus carboplatin-paclitaxel received statistically significant and clinically meaningful benefits.
Part one of the RUBY trial is also evaluating the dual-primary endpoint of overall survival (OS) in the intent-to-treat (ITT) population.
GSK senior vice-president and oncology development global head Hesham Abdullah stated: “We are excited about this initial filing for this potential new indication for dostarlimab in the patient population that demonstrated the strongest treatment effect in the phase III RUBY trial.
“Long-term outcomes for patients with primary advanced or recurrent endometrial cancer remain poor, and there is an urgent need to evolve the current standard of care, which is platinum-based chemotherapy.”
The company stated that its sBLA is being reviewed by health authorities in the US, Singapore, Canada, the UK, Switzerland and Australia under the FDA Project Orbis framework.