AstraZeneca and MSD announce Lynparza is approved by FDA for adult patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer.
AstraZeneca and MSD have announced that the US Food and Drug Administration (FDA) has approved Lynparza for the maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA-mutated (gBRCAm or sBRCAm) advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy, as detected by an FDA-approved companion diagnostic test.
This year Lynparza has also been granted ODD by FDA for pancreatic cancer and developments where made in prostate cancer
This is the first regulatory approval for a PARP inhibitor in the 1st-line maintenance setting for BRCAm advanced ovarian cancer. Lynparza is approved by FDA based on positive results from the pivotal Phase III SOLO-1 trial in which Lynparza reduced the risk of disease progression or death by 70 percent in patients with BRCAm advanced ovarian cancer who were in complete or partial response to platinum-based chemotherapy compared to placebo following platinum-based chemotherapy. The safety profile of Lynparza was consistent with previous trials.
“This approval will likely change the way we treat women with BRCA-mutated advanced ovarian cancer”
In the SOLO-1 trial, with median 41 months of follow-up, the median progression-free survival (PFS) for patients treated with Lynparza was not reached compared to 13.8 months for patients treated with placebo. Sixty percent of patients receiving Lynparza remained progression-free at three years compared to 27 percent of patients receiving placebo. The data from the SOLO-1 trial can be found in the 21 October 2018 online issue of the New England Journal of Medicine.
Dave Fredrickson, Executive Vice President, Head of the Oncology Business Unit, AstraZeneca, said: “Women with ovarian cancer are often first diagnosed with advanced disease, which is associated with poor outcomes. In SOLO-1, Lynparza in the first-line maintenance setting reduced the risk of disease progression or death by 70 percent for patients with BRCAm advanced ovarian cancer.”
Commenting on the news that Lynparza is approved by FDA Roy Baynes, Senior Vice President and Head of Global Clinical Development, Chief Medical Officer, MSD Research Laboratories, said: “The expanded approval of Lynparza based upon the SOLO-1 trial has the potential to change medical practice and reinforces the importance of knowing a woman’s BRCA status at diagnosis.”
Kathleen Moore, co-principal investigator of the SOLO-1 trial and Associate Director for Clinical Research, Stephenson Cancer Center at The University of Oklahoma, Oklahoma City, Oklahoma, said: “SOLO-1 is truly a landmark trial in gynecologic cancer. 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.”
AstraZeneca and MSD are exploring additional trials in advanced ovarian cancer, including the ongoing GINECO/ENGOTov25 Phase III trial, PAOLA-1. This trial is testing the effect of Lynparza in combination with bevacizumab as a maintenance treatment for patients with newly-diagnosed advanced ovarian cancer, regardless of their BRCA status. Results are expected during the second half of 2019.