AstraZeneca’s Lynparza receives CHMP backing for ovarian cancer approval

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.

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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