Astra and MSD get positive cancer news from EU agency

AstraZeneca and US partner Merck & Co (MSD) have received a positive opinion from European drug regulators over their ovarian, fallopian tube, or peritoneal cancer therapy.

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency indicated they were likely to recommend marketing approval for AstraZeneca and MSD's olaparib tablets, branded as Lynparza, as a twice daily maintenance therapy for patients who are in complete response or partial response to platinum-based chemotherapy.

Lynparza is recommended for treatment in this setting regardless of patients' BRCA mutation status.

Sean Bohen, Astra's chief medical officer, said: "The data show 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. It also offers a well-characterised safety and tolerability profile, which is critical to help enable patients to stay on treatment."

The CHMP recommendation was based on two randomised trials, SOLO-2 and Study 19, which showed Lynparza reduced the risk of disease progression or death for platinum-sensitive relapsed patients compared to placebo.