Lynparza is an advanced PARP inhibitor and the targeted treatment to block DNA damage response (DDR) in cells or tumours
Lynparza plus bevacizumab approved in the US for treating ovarian cancer. (Credit: AstraZeneca.)
AstraZeneca and Merck Sharp & Dohme (MSD) have secured the US Food and Drug Administration (FDA) approval for Lynparza (olaparib) in combination with bevacizumab to treat a type of ovarian cancer.
The regimen has been indicated for treating advanced epithelial ovarian, fallopian tube or primary peritoneal cancer adult patients, who are responding to 1st-line platinum-based chemotherapy and whose cancer is associated with homologous recombination deficiency (HRD) positive status.
The HRD positive status of the patients is defined by either a deleterious or suspected deleterious BRCA mutation, or genomic instability. An FDA-approved companion diagnostic test will be deployed to select patients for therapy.
AstraZeneca oncology business unit executive vice president Dave Fredrickson said: “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.
“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.”
The FDA approval for Lynparza plus bevacizumab was based on analysis of Phase 3 PAOLA-1 clinical trial
Lynparza is an advanced PARP inhibitor and the targeted treatment to block DNA damage response (DDR) in cells or tumours with a deficiency in homologous recombination repair, including mutations in BRCA1 or BRCA2.
MSD Research Laboratories chief medical officer, senior vice president and global clinical development head Roy Baynes said: “Advances in understanding the role of biomarkers and PARP inhibition have fundamentally changed how physicians treat this aggressive type of cancer.
“Today’s approval based on the PAOLA-1 trial highlights the importance of HRD testing at diagnosis to identify those who may benefit from Lynparza in combination with bevacizumab as a 1st-line maintenance treatment.”
The FDA approval was based on a biomarker subgroup analysis of Phase 3 PAOLA-1 trial which demonstrated that Lynparza plus bevacizumab would reduce the risk of disease progression or death.
In addition, the clinical trial showed that the addition of Lynparza would improve progression-free survival (PFS) compared to bevacizumab alone in patients with HRD-positive advanced ovarian cancer.
Lynparza is currently being reviewed in the EU, Japan and other countries based on results from the PAOLA-1 clinical trial. The drug is being tested as a monotherapy to treat patients with germline BRCA-mutated high-risk HER2-negative primary breast cancer in the Phase 3 OlympiA trial.
PAOLA-1 trial principal investigator Isabelle Ray-Coquard said: “Ovarian cancer is a devastating disease. The magnitude of benefit in HRD-positive patients in the PAOLA-1 trial is impactful.
“The combination of Lynparza and bevacizumab now provides women with HRD-positive advanced ovarian cancer with a new standard of care and I look forward to seeing this translate into clinical practice.”