Olaparib Granted Priority Review for Adjuvant Treatment of BRCA-Mutated, HER2-Negative High-Risk Early Breast Cancer

Officials with the FDA have granted priority review to olaparib (Lynparza; AstraZeneca and MSD) for the treatment of patient with BRCA-mutated, human epidermal growth factor 2 (HER2)-negative high-risk early breast cancer who have already received chemotherapy either before or after surgery.

Priority review is granted to applications for medicines that offer significant advantages over available treatments by demonstrating improvements in safety or efficacy, preventing serious conditions, or enhancing patient compliance. The Prescription Drug User Fee Act date is during the first quarter of 2022.

Olaparib is a first-in-class poly adenosine diphosphate-ribose polymerase (PARP) inhibitor and is the first targeted treatment to block DNA damage response in cells or tumors with a deficiency in homologous recombination repair, such as those with mutations in BRCA1 or BRCA2, or those in which deficiency is induced by other agents.

Breast cancer is now the most commonly diagnosed cancer worldwide, with an estimated 2.3 million diagnoses in 2020. According to the press release, nearly 91% of all breast cancer patients are diagnosed at an early stage of disease and BRCA mutations are found in approximately 5% of patients. Early breast cancer is defined as disease that is confined to the breast either with or without regional lymph node involvement and in the absence of distance metastatic disease.

The supplemental New Drug Application was based on results from the OlympiA phase 3 trial, which found that olaparib demonstrated a statistically significant and clinically meaningful improvement in invasive disease-free survival. OlympiA is a double-blind, parallel group, placebo-controlled, multicenter trial.

According to the press release, treatment with olaparib reduced the risk of invasive breast cancer recurrence, second cancers, or death by 42% compared with placebo. The safety and tolerability of olaparib was similar to findings in previous clinical trials.

Olaparib is currently approved for the treatment of patients with germline, BRCA-mutated, HER2-negative, metastatic breast cancer that was previously treated with chemotherapy. This approval was based on results from the OlympiAD phase 3 trial.

REFERENCE

Lynparza granted Priority Review in the US for BRCA-mutated HER2-negative high-risk early breast cancer. News release. AstraZeneca; November 30, 2021. Accessed December 3, 2021. https://www.astrazeneca.com/media-centre/press-releases/2021/lynparza-granted-fda-priority-review-for-olympia.html