Lynparza approved in US as treatment for high-risk early breast cancer

USA – The FDA has expanded Lynparza (olaparib) approval by AstraZeneca and Merck & Co. to include adjuvant treatment of germline BRCA-mutated (gBRCAm) HER2-negative, high-risk, early breast cancer in patients who had already received chemotherapy, either before or after surgery.

According to the companies, the decision makes the oral PARP inhibitor the first approved medicine targeting BRCA mutations in early breast cancer.

The filing was supported by findings from the Phase III OlympiA trial, which were presented at last year’s American Society of Clinical Oncology (ASCO) meeting and published in the New England Journal of Medicine (NEJM).

Lynparza was associated with a 42% lower risk of invasive breast cancer recurrences, second cancers, or death in the study when compared to placebo, achieving the primary endpoint of invasive disease-free survival.

Breast cancer is the most diagnosed cancer in the world, with an estimated 2.3 million new cases diagnosed in 2020.

Almost 91 percent of all breast cancer patients in the United States are diagnosed at an early stage, and BRCA mutations are found in 5-10% of patients, the statement reads.

Overall survival benefit

In terms of the key secondary goal of overall survival (OS), the results showed that while three-year estimated OS was higher with Lynparza than with placebo, the difference was not statistically significant at the interim analysis.

However, the companies released updated OlympiA results on Friday, revealing that Lynparza did show significant and clinically meaningful OS improvement, lowering the risk of death by 32% versus placebo.

The new OS data will be presented at a virtual plenary of the European Society for Medical Oncology (ESMO) next week.

Based on the Phase III OlympiAD trial, Lynparza was already approved in the United States, the European Union, Japan, and several other countries for patients with gBRCAm, HER2-negative, metastatic breast cancer who had previously been treated with chemotherapy.

Patients with locally advanced disease are also included in this indication in the EU.

AstraZeneca reported Lynparza sales of US$1 billion in the fourth quarter of 2021, a 25% increase over the previous year.

As a result of the new US approval, the company will receive a US$175 million milestone payment from Merck under their 2017 partnership agreement for the drug.

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