US FDA accepts GSK supplemental application for Jemperli cancer drug
GSK said the US Food and Drug Administration (FDA) has accepted a supplemental Biologics License Application for its Jemperli treatment of adults with primary advanced or recurrent endometrial cancer.
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If approved, the drug, also known as dostarlimab, combined with chemotherapy, "could represent the first meaningful frontline treatment advancement in decades for patients with primary advanced or recurrent endometrial cancer". the company said on Tuesday.
Endometrial cancer is the most common gynaecologic cancer in developed countries, with about 60,000 new cases every year in the US. Around 15-20% of patients will be diagnosed with advanced disease at the time of diagnosis.
Reporting by Frank Prenesti for Sharecast.com