GSK PLC on Tuesday said the US Food & Drug Administration accepted its supplemental biologics licence application for endometrial cancer treatment dostarlimab, or Jemperli, after it was granted priority review in September.
In combination with chemotherapy, the Brentford, England-based pharmaceutical company said the treatment ‘could represent the first meaningful frontline treatment advancement in decades for patients’, if approved.
The application was based on interim analysis results from part one of the Ruby/Engot-EN6/GOG3031/NSGO phase 3 trial, which met its primary endpoint of investigator-assessed progression-free survival, demonstrating a statistically significant and clinically meaningful benefit in patients treated.
GSK said the FDA granted priority review for this application last September and assigned it a prescription drug user fee act action of September 23 this year. Dostarlimab also was recently granted breakthrough therapy designation for this potential new indication.
The supplemental biologic licence application will also be reviewed by health authorities in the Australia, Canada, Switzerland, Singapore and the UK. This is under an initiative by the FDA Oncology Center of Excellence, GSK said, which provides a framework for concurrent submission and review of oncology products among international partners.
‘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 3 Ruby trial,’ said GSK Global Head of Oncology Development Hesham Abdullah.
‘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. We look forward to working with the FDA and other health authorities as they review this application.’
Shares in GSK were down 0.1% to 1,380.80 pence each in London on Tuesday morning.
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