AstraZeneca and MSD have announced that Lynparza (olaparib) has been given the green light by the FDA for first-line maintenance therapy of BRCA-mutated advanced ovarian cancer, further expanding the drug's reach.
The decision rides on the back of Phase III data showing that in this setting Lynparza reduced the risk of disease progression or death by 70%, compared to placebo.
The SOLO-1 trial also found that 60% of patients receiving Lynparza remained progression-free at three years compared to 27% of the placebo group.
“SOLO-1 is truly a landmark trial in gynecologic cancer," said Kathleen Moore, co-principal investigator of the SOLO-1 trial and associate director for Clinical Research, Stephenson Cancer Center at The University of Oklahoma said of the approval.
"This approval will likely change the way we treat women with BRCA-mutated advanced ovarian cancer. The ability to offer this important first-line maintenance treatment option to eligible patients may slow down or even stop the natural course of disease progression.”
In addition to Lynparza, AstraZeneca and MSD are exploring additional trials in advanced ovarian cancer, including the ongoing GINECO/ENGOTov25 Phase III trial, PAOLA-1.
Within the trial they are testing the effect of Lynparza in combination with (Avastin) bevacizumab as a maintenance treatment for patients with newly-diagnosed advanced ovarian cancer, regardless of their BRCA status, with results expected during the second half of 2019.
Lynparza has become the first PARP inhibitor to be approved for first-line maintenance therapy, pushing it in-front of its rivals.