AstraZeneca's Lynparza Receives EU Approval as First-Line Maintenance Therapy for BRCA-Mutated Advanced Ovarian Cancer
AstraZeneca
Biopharmaceutical Manufacturer
European Commission
The European Commission, abbreviated as the EU Commission, is a supranational body under the European Union. Within the EU political system, the European Commission primarily undertakes executive tasks, thus being roughly equivalent to the government in a national system. However, the European Commission has other functions as well. In particular, except for the few circumstances specified in the treaties, the European Commission is the only institution with legislative power in the EU legislative process.
By Holly
Today (June 18), AstraZeneca announced that its PARP inhibitor Lynparza (olaparib) has received approval from the European Commission as a first-line maintenance therapy for patients with advanced ovarian cancer harboring BRCA mutations. This approval also makes Lynparza the first PARP inhibitor approved in the EU for first-line maintenance treatment of this indication.
This approval is based on the results of the pivotal Phase III clinical trial SOLO-1, a Phase III, randomized, double-blind, placebo-controlled, multicenter study designed to evaluate the efficacy and safety of Lynparza tablets (300 mg twice daily) as maintenance monotherapy versus placebo in patients with BRCA-mutated advanced ovarian cancer. The results demonstrated that, compared with the placebo group, the Lynparza treatment group achieved a statistically significant and clinically meaningful improvement in progression-free survival (PFS), with a 70% reduction in the risk of disease progression or death (HR=0.30 [95% CI=0.23-0.41], p<0.001). At 41 months of follow-up, the median PFS had not been reached in the Lynparza treatment group, whereas it was 13.8 months in the placebo group. Sixty percent of patients in the Lynparza treatment group remained progression-free at 36 months, compared with 27% in the placebo group.
Regarding safety, SOLO-1 was consistent with previous studies. The most common adverse events (AEs) were nausea (77%), fatigue (63%), vomiting (40%), anemia (39%), and diarrhea (34%).
It is worth noting that, based on the results of the SOLO-1 study, Lynparza was approved by the U.S. FDA in December 2018 for first-line maintenance treatment of BRCA-mutated advanced ovarian cancer.
Lynparza is the first PARP inhibitor marketed globally, initially approved by the U.S. FDA in December 2014 for patients with advanced ovarian cancer carrying harmful or suspected harmful germline BRCA mutations (gBRCAm). To date, the drug has been approved in more than 60 countries/regions worldwide for platinum-sensitive recurrent ovarian cancer (regardless of BRCA status). Additionally, it has been approved in the United States, Canada, Japan, and Australia for HER2-negative metastatic breast cancer with germline BRCA mutations.
In China, Lynparza (Lipuzhuo) was approved by the National Medical Products Administration in August 2018 for maintenance treatment of platinum-sensitive recurrent ovarian cancer. It is also the first targeted therapy approved for the treatment of ovarian cancer in China, holding significant importance for ovarian cancer treatment in the country.
AstraZeneca and Merck & Co. entered into a global strategic oncology collaboration in July 2017 to jointly develop and commercialize Lynparza and another MEK inhibitor, selumetinib. Under the collaboration agreement with Merck & Co., AstraZeneca will receive a $30 million milestone payment upon the approval of Lynparza. Currently, both parties are conducting multiple clinical studies to evaluate the potential of Lynparza across a broad range of tumor types, including breast cancer, prostate cancer, and pancreatic cancer.
*Disclaimer: This article was written by an author contributing to Sina Medical News. The views expressed are solely those of the author and do not represent the position of Sina Medical News.