Business
Lynparza approved in the EU for wider ovarian use
Lynparza approved in the EU for wider ovarian use.
About this update from Astrazeneca Plc
[{"type":"text","content":"\n \n \n \n RNS Number : 3099E\n AstraZeneca PLC\n 05 November 2020\n \n \n \n 5 November 2020 07:15 GMT\n \n \n \n Lynparza \n \n \n approved in the EU as 1st-line maintenance treatment\nwith bevacizumab for HRD-positive advanced ovarian cancer\n \n \n \n \n \n Patients treated with Lynparza and bevacizumab lived without disease\n progression for a median of 37.2 months vs. 17.7 months with bevacizumab alone\n \n One in two women with advanced ovarian cancer has an HRD-positive tumour\n \n \n \n \n AstraZeneca and MSD's Lynparza (olaparib) has been approved in the European Union (EU) for the 1st-line maintenance treatment with bevacizumab of patients with homologous recombination deficient (HRD)-positive advanced ovarian cancer.\n \n \n \n \n \n Ovarian cancer is the fifth most common cause of cancer death in the EU and the five-year survival rate is approximately 45%, due partly because women are often diagnosed with advanced disease (Stage III or IV).1-3\n \n \n \n \n \n The approval by the European Commission was based on a biomarker subgroup analysis of the PAOLA-1 Phase III trial which showed Lynparza, in combination with bevacizumab maintenance treatment, demonstrated a substantial progression-free survival (PFS) improvement versus bevacizumab alone for patients with HRD-positive advanced ovarian cancer. It follows the \n \n recommendation for approval\n \n by the Committee for Medicinal Products for Human Use of the European Medicines Agency in September 2020.\n \n \n \n \n \n Isabelle Ray-Coquard, principal investigator of the PAOLA-1 Phase III trial and medical oncologist, Centre Léon Bérard and President of the GINECO group, Paris, France, said: \"For women with advanced ovarian cancer, the goal of 1st-line treatment is to delay disease progression for as long as possible with the intent of achieving long-term remission. Unfortunately, once a patient's cancer recurs, it historically has been incurable. Lynparza together with bevacizumab has demonstrated an impressive median progression-free survival benefit of more than three years and is poised to become the standard of care for eligible patients with HRD-positive tumours in the EU.\"\n \n \n \n \n \n Dave Fredrickson, Executive Vice President, Oncology Business Unit, said: \"Half of all newly diagnosed patients w...