Lynparza combo authorised in US for first-line maintenance of HRD-positive advanced ovarian cancer
Lynparza (olaparib), developed by AstraZeneca and MSD, has secured FDA approval when paired with bevacizumab as a first-line maintenance treatment for homologous recombination deficiency (HRD)-positive advanced epithelial ovarian, fallopian tube or primary peritoneal cancer.
The indication covers adult patients who have completely or partially responded to first-line platinum-based chemotherapy and whose HRD-positive status is defined by either a deleterious or suspected deleterious BRCA mutation or genomic instability. HRD mutations are present in around half or all ovarian cancer cases.
In a biomarker subgroup analysis of Phase 3 trial data, the combo reduced the risk of disease progression or death by 67% and extended progression-free survival by a median 37.2 month compared to 17.7 months with bevacizumab alone.
“This approval represents another milestone for Lynparza in patients with ovarian cancer. The median progression-free survival of more than three years offers new hope for more women to delay relapse in this difficult-to-treat disease,” explained Dave Fredrickson, Executive Vice President at AstraZeneca’s Oncology Business Unit. “These results further establish that HRD-positive is a distinct subset of ovarian cancer, and HRD testing is now a critical component for the diagnosis and tailoring of treatment for women with advanced ovarian cancer.”
Alongside this latest approval, MSD and AZ are also pursuing regulatory authorisation for the combo in the EU, Japan and other regions.
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