FDA approves Lynparza for treatment of certain high-risk, early-stage breast cancer patients

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

FDA approval of Lynparza in this setting is indicated for patients who have previously received chemotherapy before or after surgery to remove affected tumors.

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

The FDA green light to the PARP inhibitor Lynparza was boosted by data from the phase 3 Olympia trial. Here, 1,836 patients with HER2-negative breast cancer with a germline BRCA mutation were randomized to receive either oral Lynparza (921 patients) twice daily for one year or placebo (915 patients) . In addition, patients had to have been treated for early-stage (stage 2 to 3) breast cancer and had undergone surgery and chemotherapy, with or without radiation therapy.

The results showed that treatment with Lynparza reduced the risk of recurrence of invasive breast cancer, secondary cancers or death by 42% compared to placebo. Additionally, recently published data showed that the study drug reduced the risk of death by 32% compared to placebo.

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

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

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