Ovarian cancer therapy Lynparza has been granted a positive option by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency which will now recommend a marketing authorisation.
Lynparza is recommended for treatment in this setting regardless of patients’ BRCA mutation status.
Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer at AstraZeneca, 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.”
Roy Baynes, Senior Vice President and Head of Global Clinical Development, Chief Medical Officer, MSD Research Laboratories, said: “We welcome this positive opinion based upon data which indicate the potential impact for Lynparza as maintenance therapy for women with platinum-sensitive relapsed ovarian cancer.”
The recommendation is 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.
This follows news in January where Lynparza was approved in the US for use beyond ovarian cancer.