EU puts Cambridge drug in front line of fight against ovarian cancer
The European Commission has approved a Cambridge-born drug as a front-line weapon in the fight against BRCA-mutated ovarian cancer.
Cambridge-based AstraZeneca and global partner MSD Inc earned the approval after pivotal Phase III trials showed that 60 per cent of patients receiving Lynparza remained free of disease progression after three years versus 27 per cent on placebo.
Dave Fredrickson, executive VP at AstraZeneca’s Oncology Business Unit, said: “This approval sets the stage for a new standard of care in the EU for women with ovarian cancer and a BRCA mutation.
“The goals of front-line therapy have always been long-term remission and even cure, yet currently 70 per cent of patients relapse within three years of initial treatment.
“The progression-free survival benefit of Lynparza observed in SOLO-1 represents a major step forward in our ambition to help transform patient outcomes.”
This is the third indication for Lynparza in the EU. AstraZeneca and MSD are exploring additional trials in ovarian cancer, including the ongoing Phase III PAOLA-1 trial, which is testing Lynparza in combination with bevacizumab as a 1st-line maintenance treatment for women with newly-diagnosed, advanced, stage IIIB-IV high grade serous or endometrioid ovarian cancer, regardless of BRCA mutation status.
The journey started in Professor Steve Jackson’s Cambridge University laboratory. His startup company, KuDOS initially developed the drug.
Professor Jackson told Business Weekly: “This is a wonderful piece of news because it means that many more ovarian cancer sufferers in the EU with BRCA-mutated cancers are now set to benefit from Lynparza.
“The drug is the first PARP-inhibitor drug approved for this indication in the EU. Based on the stunning data from the pivotal SOLO-1 clinical trial, it seems that this landmark approval will lead to truly significant medical benefits.”