Endometrial cancer: France approves early GSK drug Jemperli
While endometrial cancer is still the cause of numerous deaths in France, French health authorities announced on Tuesday that they had approved, according to a so-called early access procedure, a treatment developed by the British giant GSK.
“Since October 23, the drug Jemperli – created from the dostarlimab molecule – has been available in early access for women with newly diagnosed or recurrent advanced endometrial cancer,” the National Agency announced in a press release. medicine safety (ANSM).
Endometrial cancerwhich usually 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 nearly 10,000 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.
Authorized in France before the European green light
Jemperli, which must be administered in conjunction with chemotherapy, has already been approved by other health authorities to treat this cancer, including in the United States at the end of the summer.
A file is currently being examined by the European Union (EU) medicines authority, the EMA, but it has not yet made a decision.
The ANSM therefore authorized this drug before the European green light, even if it does so by limiting for the moment the prescription conditions according to the early access procedure.
Only doctors competent in oncology will be able to prescribe it and particular attention will be paid to monitoring side effects.
But there is a “strong presumption of effectiveness and safety of Jemperli” in the treatment of endometrial cancer, according to the ANSM.
Some criticisms
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 worsening. of his illness.
But this indicator is subject to criticism among certain specialists, for whom it cannot replace data on “overall survival”, the latter being more telling on the effects in terms of reducing mortality.
However, GSK has just published a press release ensuring that its latest study also shows an improvement in this indicator when Jemperli is used against endometrial cancer, an announcement likely to facilitate the outright approval of this treatment.
