GSK nears green light for Jemperli usage in Europe
Pharma giant GSK has announced that European experts recommended the approval of its Jerperli drug for the treatment of a specific type of endometrial cancer – paving the way for marketing authorisation by the continent's regulatory body.
Source: Sharecast
The Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a "positive opinion recommending approval" of Jerperli, otherwise known as dostarlimab, which when used alongside chemotherapy can used for patients with mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) primary advanced or recurrent endometrial cancer and who are candidates for systemic therapy.
Hesham Abdullah, senior vice president and head of oncology within R&D at GSK, said: "If approved, dostarlimab plus chemotherapy will be the first new treatment option in decades for these patients in the European Union, offering long-awaited new hope for improved long-term outcomes.
"This opinion further reinforces our confidence in dostarlimab's important role in the immuno-oncology treatment landscape."
GSK said it is expecting a decision from the European Commission by the end off this year.
Jemperli remains under review in Australia, Canada, Switzerland and Singapore, but was approved this summer already in the US and UK.
Endometrial cancer, the most common gynaecologic cancer in developed countries, affects 417,000 new cases each year, but incidence rates are expected to rise by almost 40% by 2040, GSK said. 15-20% of people with the cancer will be diagnosed with advanced disease at the time of diagnosis, while approximately 20-29% of all endometrial cancers are dMMR/MSI-H.