AstraZeneca’s Lynparza gets EU approval for treatment of early-stage breast cancer

According to a report by the International Agency for Research on Cancer, breast cancer is the most diagnosed cancer across the world with an estimated 2.3 million patients diagnosed in 2020.

AstraZeneca’s Lynparza gets EU approval for treatment of early-stage breast cancer
The study included 1,600 women with early breast cancer who were planned to be treated with surgery. (File)

AstraZeneca announced on Thursday that its drug Lynparza, developed with U.S.-based Merck & Co, was approved by the European Union as an adjuvant treatment for patients with a form of genetically mutated early-stage breast cancer.

According to the company’s statement, the approval was based on results from the OlympiA Phase III trial published in The New England Journal of Medicine in June last year. The company also stated that it follows the recommendation for approval in the EU by the Committee for Medicinal Products for Human Use of Lynparza in this setting.

“Lynparza also demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS), reducing the risk of death by 32 percent versus placebo. The safety and tolerability profile of Lynparza in this trial was in line with that observed in prior clinical trials,” the company stated on Thursday.

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According to a report by the International Agency for Research on Cancer, breast cancer is the most diagnosed cancer across the world with an estimated 2.3 million patients diagnosed in 2020. Studies reveal that approximately 90 percent of all breast cancer patients worldwide are diagnosed with early breast cancer and BRCA mutations are found in approximately 10 percent of HER2-negative patients in Europe.

“Today’s approval marks a new era of care in Europe for patients with an inherited form of breast cancer. For patients with high-risk early-stage breast cancer, including those with germline BRCA mutations, recurrence rates remain unacceptably high, with more than one in four of these patients seeing their cancer return following surgery and systemic treatment. Olaparib is the first PARP inhibitor to demonstrate improved overall survival for high-risk early-stage breast cancer patients with germline BRCA mutations and I am hopeful it will become a new standard of care,” Professor Andrew Tutt, Global Chair of the OlympiA Phase III trial and Professor of Oncology at The Institute of Cancer Research, London and King’s College London, said in a statement.

In March this year, Lynparza was approved in the US for the treatment of gBRCAm, HER2-negative high-risk early breast cancer. In a statement the company informed that Lynparza is also approved in the US, EU, Japan, and many other countries for the treatment of patients with gBRCAm, HER2-negative, metastatic breast cancer previously treated with chemotherapy based on results from the OlympiAD Phase III trial.

In the EU, this indication also includes patients with locally advanced breast cancer, the company stated.

“With this approval, Lynparza is now the first and only PARP inhibitor available for patients with germline BRCA-mutated HER2-negative early breast cancer in Europe. We can now bring the benefits of Lynparza to this earlier setting to help reduce the risk of life-threatening recurrence,” Dave Fredrickson, Executive Vice President, Oncology Business Unit, AstraZeneca, said in a statement on Thursday.

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