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November 30, 2021
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FDA grants priority review to Lynparza for certain patients with high-risk breast cancer

Source:

Press Release

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The FDA granted priority review to olaparib for adjuvant treatment of certain patients with high-risk breast cancer.

The designation applies to use of the agent by patients with BRCA-mutated, HER2-negative, high-risk early breast cancer who received chemotherapy before or after surgery.

One year of adjuvant olaparib significantly extended invasive and distant DFS among patients with high-risk, HER2-negative early-stage breast cancer and germline BRCA1/BRCA2 mutations.
Data were derived from Tutt A, et al. Abstract LBA1. Presented at: ASCO Annual Meeting (virtual meeting); June 4-8, 2021.

Olaparib (Lynparza; AstraZeneca, Merck) is a poly(ADP-ribose) polymerase (PARP) inhibitor approved in the United States for multiple cancer indications.

A supplemental new drug application is based on results of the randomized phase 3 OlympiA study, which included 1,836 patients with germline BRCA-mutated, HER2-negative, stage II to stage III breast cancer who underwent surgery and standard neoadjuvant (50.1%) or adjuvant (49.9%) chemotherapy with or without radiotherapy. All patients were deemed at high risk for cancer recurrence.

Researchers randomly assigned patients 1:1 to receive 1 year of continuous treatment with 300 mg oral olaparib twice daily (n = 921; median age, 42 years; range, 36-49) or placebo (n = 915; median age, 43 years; range, 36-50).

Invasive DFS — which included local or metastatic recurrence, other new cancers and death of any cause — in the intent-to-treat population served as the study’s primary endpoint. Secondary endpoints included distant DFS, OS and safety.

As Healio previously reported, results showed olaparib reduced risk for invasive breast cancer recurrence, second cancers or death by 42% compared with placebo (HR = 0.58; 99.5% CI, 0.41-0.82).

Researchers reported 3-year invasive DFS rates of 85.9% with olaparib and 77.1% with placebo (difference, 8.8 percentage points; 95% CI, 4.5-13).

Olaparib exhibited a safety profile consistent with that observed in prior trials.

The safety and tolerability profile of Lynparza in this trial was in line with that observed in prior clinical trials.

The FDA is expected to make a decision on approval for this indication during the first quarter of 2022.