On July 31st, 2023, GSK – a global pharmaceutical company shared that their anticancer medication Jemperli (Dostarlimab -glxy) has been approved by the US Food and Drug Administration (FDA) for use in combination with chemotherapy drugs paclitaxel and carboplatin.
GSK’s Jemperli was first approved by the FDA in April 2021 for monotherapy in adult patients with advanced or recurrent endometrial cancer that is DNA mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H).
The expanded approval of this medication comes after the latest clinical trial ‘RUBY’ which demonstrated a positive impact of Jemperli combined with Chemotherapy in all patients. The recent FDA approval of this combination of treatments is a major advancement in the treatment of endometrial cancer in adult patients.
“Based on the results from the RUBY clinical trial, I look forward to the addition of Jemperli to chemotherapy becoming a new standard of care for patients.” - Matthew Powell, US Principal Investigator of the RUBY trial.
Jemperli (Dostarlimab -glxy) is a monoclonal antibody used as an anticancer medication for endometrial cancer. Endometrial cancer is a type of gynecological uterine cancer that develops in the innermost lining of the uterus – the endometrium tissue. The cancer cells developed in endometrial cancer are malignant, making it a major cause of morbidity and mortality in American women. The development of combinational therapy for major gynecological cancer is projected to boost the cancer therapeutics industry.
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Based on the trial results, the expanded approval of GSK’s Jemperli is guaranteed to positively impact the treatment of endometrial cancer, providing advanced treatment options to patients.
Hesham Abdullah, Senior Vice President, GSK said - “In the RUBY trial, Jemperli plus chemotherapy demonstrated a 71% reduction in the risk of disease progression or death versus chemotherapy in this patient population, providing a statistically significant and clinically meaningful benefit.”
Dostarlimab was first approved for the treatment of endometrial cancer in both the European Union and the United States in April 2021. In July 2023, Jemperli has been approved in combination with chemotherapy by the FDA in the United States.
It will be interesting to see how this approval impacts the market as well in upcoming times. Jemperli will now be available in the US through prescription to be used in combination with chemotherapy.