May 11, 2020
The U.S. FDA has approved a new indication for Lynparza® (olaparib), manufactured by AstraZeneca. Lynparza is now indicated for use in combination with bevacizumab to provide first-line maintenance treatment for adult patients who have advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer and meet the following requirements:
- Patients who are in complete or partial response to first-line platinum-based chemotherapy, and
- Patients whose cancer is associated with homologous recombination deficiency (HRD) positive status, defined by either a deleterious or suspected deleterious BRCA mutation and/or genomic instability.
Epithelial ovarian, fallopian tube, and primary peritoneal cancer are collectively referred to as ovarian cancer and together affect an estimated 22,000 women in the United States annually. In most instances, the disease is diagnosed when already in its advanced stages, when the five-year survival rate is only 30%. Approximately half of advanced ovarian cancers are HRD positive and are sensitive to PARP inhibitors like Lynparza that can target and kill the cancer’s cells.
In a clinical trial, Lynparza used in combination with bevacizumab reduced the risk of disease progression or death by 67% in patients who had HRD-positive advanced ovarian cancer, and improved progression-free survival (PFS). The median PFS with Lynparza and bevacizumab was 37.2 months, while the median PFS with bevacizumab alone was 17.7 months.
Recommended dosing is 300mg of Lynparza taken by mouth twice daily, with or without food, for up to two years or until disease progression or unacceptable toxicity occur. If signs of cancer remain following two years of treatment, patients may be eligible for further treatment with Lynparza if the healthcare provider has reason to believe there is potential benefit to continued therapy.
First FDA approved in 2014, Lynparza is also indicated to treat breast cancer, pancreatic cancer, and prostate cancer.