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FDA grants priority review to Lynparza for metastatic BRCA-related breast cancer
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The FDA granted priority review to olaparib for the treatment of patients with germline BRCA-mutated, HER-2-negative metastatic breast cancer who have been previously treated with chemotherapy in the neoadjuvant, adjuvant or metastatic settings.
Olaparib (Lynparza; AstraZeneca, Merck) is a PARP inhibitor approved for use in women with BRCA-related ovarian cancer.
The supplemental new drug application included positive results from the randomized, open-label, multicenter phase 3 OlympiAD trial, which evaluated the safety and efficacy of olaparib tablets in 302 patients with HER-2-negative metastatic breast cancer with germline BRCA1 or BRCA2 mutations that are predicted or suspected to be deleterious.
Researchers randomly assigned patients to receive 300 mg olaparib twice daily or physician’s choice of chemotherapy.
As HemOnc Today previously reported, a higher percentage of patients assigned olaparib experienced tumor shrinkage (60% vs. 29%).
At median follow-up of about 14 months, olaparib-treated patients experienced significantly longer median PFS (7 months vs. 4.2 months; HR = 0.58; 95% CI, 0.43-0.8).
Olaparib also extended time to investigator-assessed second progression or death (HR = 0.57; 95% CI, 0.4-0.83).
Olaparib-treated patients experienced fewer grade 3 or worse adverse events (36.6% vs. 50.5%), as well as fewer adverse events that required treatment discontinuation (4.9% vs. 7.7%).
The most common adverse events among olaparib-treated patients included nausea and anemia.
The FDA set an action date for the first quarter of next year.