23rd Apr 2021 16:08
(Alliance News) - GlaxoSmithKline PLC said Friday the European Commission has approved Jemperli for for women with recurrent or advanced dMMR endometrial cancer.
Shares in the blue-chip pharma firm were down 0.7% in London on Friday afternoon at 1,339.00 pence each.
The EU's approval follows the regulators in the US green-lighting the treatment on Thursday.
Dostarlimab, the medical name for Jemperli, is indicated for the treatment of adult patients with mismatch repair deficient, dMMR, recurrent or advanced endometrial cancer, as determined by an FDA approved test, that have progressed on or following prior treatment with a platinum containing regimen, GSK noted.
It continued: "This indication is approved under accelerated approval based on tumour response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial."
The EU and US approval is based on the Garnet study, which GSK said is the largest dataset of anti-PD-1 monotherapy treatment of women with endometrial cancer.
Results from the study showed an overall response rate of 42%. Of those that responded, 93.3% demonstrated a duration of response of 6 months or more.
The approval makes dostarlimab the first anti-PD-1 therapy available for endometrial cancer in Europe.
Hal Barron, chief scientific officer & President Research & Development at GSK, said: "Women with recurrent endometrial cancer, or advanced disease that has progressed on or after chemotherapy, currently have limited treatment options and a poor prognosis. Today's approval of dostarlimab means that for the first time in Europe, these women will have access to a new, innovative and much-needed therapy."
On Thursday, following the US approval, Barron said: "Unfortunately, as many as 60,000 women are diagnosed with endometrial cancer in the US each year and these women currently have limited treatment options if their disease progresses on or after first-line therapy.
"Today's approval of dostarlimab by the FDA has the potential to transform the treatment landscape for these women and demonstrates our continued commitment to helping patients with gynaecologic cancers."
By Paul McGowan; [email protected]
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