2023-12-11 14:44:49
The British pharmaceutical laboratory GSK announced on Monday that it had received the European green light to market its Jemperli treatment. The latter is used to treat patients with endometrial cancer in combination with chemotherapy. It was already available in France since October as part of a so-called early access procedure.
An announcement synonymous with hope for thousands of women. The British pharmaceutical company GlaxoSmithKline (GSK) announced on Monday that it had received the European green light to market its treatment used to treat patients with endometrial cancer in combination with chemotherapy. “The European Commission has given authorization to market Jemperli” (trade name of dostarlimab) in combination with carboplatin and paclitaxel (chemotherapy) in women suffering from an advanced form of this type of cancer, newly diagnosed or recurrent, GSK said in a press release.
This decision was taken on the basis of a study which demonstrated a positive effect of the treatment on the “progression-free survival” of cancer, that is to say the duration during which a patient does not suffer a worsening of their disease, but also on the “overall survival”.
Already authorized in France
The Jemperli drug has already been available in France since October as part of a so-called early access procedure which allows certain patients to benefit, exceptionally and temporarily, from a treatment not yet authorized. “Since October 23, the drug Jemperli, created from the molecule dostarlimab, has been available in early access for women with newly diagnosed or recurrent advanced endometrial cancer,” the National Medicines Safety Agency (ANSM) announced in a press release on October 31. The agency made its decision on the basis of a study which showed a positive effect of the treatment on the “progression-free survival” of cancer, that is to say the duration during which a patient does not experience a worsening of his disease.
Since then, only doctors competent in oncology could prescribe it and particular attention was paid to monitoring side effects.
“This combination could change the paradigm”
The move followed GSK’s request to the European Union last spring for approval of its treatment. “New treatment options are urgently needed for patients with advanced or recurrent primary endometrial cancer. (…) Patients currently face significant unmet medical needs, and this combination could change the paradigm of treatment of this disease”, Hesham Abdullah, global head of oncology development at GSK, explained at the time, quoted in the press release.
Jemperli had also already been approved by other health authorities to treat this cancer, notably in the United States at the end of the summer, following the examination of the regulatory file which had taken place during the first half of 2023.
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As a reminder, endometrial cancer, which generally affects women after menopause, develops in the inner lining of the uterus, known as the endometrium. It is one of the most common cancers, with more than 8,000 cases per year in France, and even if it has a relatively good prognosis compared to other female cancers (cervix, ovary. ..), it remains the cause of numerous deaths. Note that for between 15 to 20% of patients with endometrial cancer, the diagnosis is established at an advanced stage of the disease, adds the laboratory.
A. LG with AFP
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