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AstraZeneca’s Lynparza receives positive EU CHMP opinion

David Fredrickson

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion, recommending Lynparza (olaparib) as a 1st-line maintenance treatment of BRCA-mutated advanced ovarian cancer.

The recommendation is for the use of Lynparza tablets as a maintenance treatment of adult patients with advanced (FIGO stages III and IV) BRCA1/2-mutated (germline and/or somatic) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy.

“There remains a significant unmet need in the treatment of advanced ovarian cancer as 70% of women globally relapse within the first three years after their initial treatment. The results of SOLO-1 demonstrate the potential of using Lynparza earlier in the treatment pathway as a maintenance therapy, and reinforce the importance of identifying a patient’s BRCA mutation status as soon as they are diagnosed,” says Dave Fredrickson, Executive Vice President, Oncology, AstraZeneca.


SOLO-1 trial

The positive opinion is based on data from the pivotal Phase III SOLO-1 trial which showed that Lynparza reduced the risk of disease progression or death by 70% vs. placebo following response to platinum-based chemotherapy (HR 0.30 [95% CI 0.23-0.41], p<0.001). Of those patients receiving Lynparza, 60.4% remained progression-free at 36 months vs. 26.9% of women in the placebo arm.

Lynparza is currently approved in 64 countries, including those in the EU, for the maintenance treatment of platinum-sensitive relapsed ovarian cancer regardless of BRCA status. It is approved in the US as 1st-line maintenance treatment of BRCAm advanced ovarian cancer following response to platinum-based chemotherapy. It is also approved in 38 countries, including the US, countries in the EU and Japan, for germline BRCAm HER2-negative metastatic breast cancer previously treated with chemotherapy; in the EU this includes locally advanced breast cancer. Regulatory reviews are underway in other jurisdictions for both ovarian cancer and breast cancer.

Photo of Dave Fredrickson: AstraZeneca