AstraZeneca and Merck Sharp and Dohme have received a recommendation for EU approval of Lynparza as a treatment for ovarian cancer.
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion recommending Lynparza as a maintenance therapy for patients with platinum-sensitive relapsed high-grade, epithelial ovarian, fallopian tube or primary peritoneal cancer.
“AstraZeneca and Merck Sharp and Dohme have received CHMP backing for EU approval of Lynparza as a treatment for ovarian cancer.“
Lynparza has been endorsed for use in this setting regardless of patients' BRCA mutation status, and is intended for individuals who have experienced a complete or partial response to platinum-based chemotherapy.
The CHMP recommendation is based on two randomised trials, SOLO-2 and Study 19, which have demonstrated that Lynparza can reduce the risk of disease progression or death for platinum-sensitive relapsed patients compared to placebo.
Sean Bohen, executive vice-president for global medicines development and chief medical officer at AstraZeneca, said: "The data shows that Lynparza provides long-term disease control, delaying the need for further chemotherapy for this broader group of women with platinum-sensitive relapsed ovarian cancer, irrespective of their BRCA status."
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