FDA Approves Lynparza for Treatment of Certain Patients With High-Risk, Early-Stage Breast Cancer

The FDA’s decision to OK Lynparza is based on data from the OlympiA trial, which showed that Lynparza reduced the risk of invasive breast cancer recurrences, second cancers or death by 42% versus placebo after initial treatment with chemotherapy.

The Food and Drug Administration (FDA) on Friday approved Lynparza (olaparib) as an adjuvant treatment for patients with germline BRCA-mutated HER2-negative high-risk early-stage breast cancer, according to the drug’s manufacturer, AstraZeneca.

The FDA’s approval of Lynparza in this setting is indicated for patients who were previously treated with chemotherapy before or after surgery to remove the affected tumors.

This decision, according to the press release from AstraZeneca, marks the first and only approved therapy that targets BRCA mutations in patients with early-stage breast cancer.

The FDA’s greenlight of the PARP inhibitor Lynparza was spurred by data out of the phase 3 OlympiA trial. Here, 1,836 patients with HER2-negative breast cancer harboring a germline BRCA mutation were randomized to receive either oral Lynparza (921 patients) twice daily for one year or placebo (915 patients). Additionally, patients needed to have been treated for early stage (stage 2 to 3) breast cancer and have completed surgery and chemotherapy, with or without radiotherapy.

The findings demonstrated that treatment with Lynparza reduced the risk of invasive breast cancer recurrences, second cancers or death by 42% versus placebo. Moreover, newly released data showed that the study drug reduced the risk of death by 32% when compared with placebo.

These data, according to the press release, are scheduled to be presented at an upcoming medical conference.

“Today’s approval of (Lynparza) is great news for patients with a specific inherited form of breast cancer. Most breast cancers are identified in the early stages and many patients will do very well, but for those with higher risk disease at diagnosis, the risk of cancer returning can be unacceptably high and new treatment options are needed,” Andrew Tutt, global chair of the phase 3 OlympiA trial and a professor of oncology at The Institute of Cancer Research in London, said in the release. “OlympiA has shown that identifying a BRCA1/2 mutation in women with high-risk disease opens the additional option of eligibility for (Lynparza) treatment, which reduces the risk of recurrence and improves survival for these breast cancer patients.”

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