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The regulatory agency has set a Prescription Drug User Fee Act date during the first quarter of 2022
The FDA has accepted and granted priority review of the supplemental new drug application for Lynparza (olaparib) for the adjuvant treatment of patients with BRCA-mutated, human epidermal growth factor receptor 2 (HER2)-negative high-risk early breast cancer. The FDA has set a Prescription Drug User Fee Act date during the first quarter of 2022.
The application was based on the results from the phase 3 OlympiA trial, which showed the therapy led to clinically meaningful improvement in invasive disease-free survival (iDFS), reducing the risk of invasive breast cancer recurrence, second cancers or death by 42% versus placebo.
The safety and tolerability did not differ from that observed in prior clinical trials. The most common adverse events were nausea, fatigue, anemia, and vomiting. Grade ≥3 AEs were anemia, neutropenia, leukopenia, fatigue, and nausea. About 10% of patients treated with Lynparza discontinued treatment due to adverse events.
“Patients with early-stage breast cancer who have inherited BRCA mutations are typically diagnosed at a younger age compared to those without such a mutation. Olaparib has the potential to be used as a follow-on to all the standard initial breast cancer treatments to reduce the rate of life-threatening recurrence and cancer spread for many patients identified through genetic testing to have mutations in these genes,” Andrew Tutt, chair of the OlympiA trial steering committee and professor of Oncology at The Institute of Cancer Research, London, said in a statement in June when the study findings were released.
Lynparza is approved in the United States, EU, Japan and several other countries for the treatment of patients with germline BRCA-mutated, HER2-negative metastatic breast cancer previously treated with chemotherapy.
Lynparza was developed and is commercialized jointly by AstraZeneca and Merck. It is a first-in-class PARP inhibitor and the first targeted treatment to block DNA damage response in tumors harboring a deficiency in mutations in BRCA1 and/or BRCA2.
Breast cancer is now the most diagnosed cancer worldwide, with an estimated 2.3 million patients diagnosed in 2020. Nearly 91% of all breast cancer patients are diagnosed at an early stage of disease
Research of Lynparza continues. It is being studied in combination with abiraterone to treat prostate cancer, and as a monotherapy for ovarian cancer.