Lynparza approved for HRD-positive ovarian cancer maintenance treatment in US
The US FDA has approved Lynparza in combination with bevacizumab for maintenance treatment of advanced ovarian cancer patients with HRD-positive status.
AstraZeneca and MSD announced today that Lynparza (olaparib) in combination with bevacizumab has received US FDA approval. The approval is for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who have responded to first-line platinum-based chemotherapy and whose cancer is HRD-positive.
The decision was based on a subgroup analysis from the Phase III PAOLA-1 trial. The study showed that Lynparza plus bevacizumab reduced the risk of disease progression or death by 67% in HRD-positive advanced ovarian cancer patients. Progression-free survival (PFS) improved to a median of 37.2 months, compared to 17.7 months for patients treated with bevacizumab alone. Approximately half of patients with advanced ovarian cancer have HRD-positive tumors.
This approval provides a new treatment option for patients with HRD-positive advanced ovarian cancer, aiming to delay disease recurrence. HRD testing is now considered a critical component for identifying patients who may benefit from this combination therapy as a first-line maintenance treatment.
Regulatory reviews based on the PAOLA-1 trial results are underway in the EU, Japan, and other countries. Following this US approval, AstraZeneca will receive $100 million in collaboration revenue from MSD.