Olaparib Granted FDA Priority Review for Reducing Early Breast Cancer Recurrence Risk by 42%

On November 30, 2021, AstraZeneca announced that the US FDA had granted priority review status to the supplemental New Drug Application (sNDA) for the PARP inhibitor olaparib (brand name: Lynparza) as an adjuvant treatment for high-risk HER2-negative early breast cancer patients with BRCA mutations who have already received neoadjuvant or adjuvant chemotherapy.

In 2020, approximately 2.3 million women worldwide were diagnosed with breast cancer. BRCA mutations occur in about 5% of breast cancer patients. Nearly 91% of breast cancer patients are still in the early stages of the disease at the time of diagnosis.

BRCA is an important protein for repairing DNA damage in cells, and PARP also plays a significant role in DNA damage repair. In tumor cells carrying BRCA gene mutations, the BRCA-mediated DNA damage repair pathway is already disrupted. The addition of a PARP inhibitor will lead to cell death due to excessive DNA damage that cannot be repaired. Olaparib is a "first-in-class" PARP inhibitor jointly developed by AstraZeneca and MSD (Merck & Co., Inc.). It targets the DNA Damage Response (DDR) pathway, utilizing the principle of "synthetic lethality" to kill cancer cells without affecting healthy cells.

Previously, it had already received approval from the U.S. FDA for the treatment of various cancer types, including advanced ovarian cancer, breast cancer, and pancreatic cancer, associated with germline BRCA mutations. Meanwhile, Olaparib (brand name Lynparza) was also the first targeted new drug for ovarian cancer to be approved for marketing in China. In November 2019, Olaparib received another approval from the NMPA for first-line maintenance treatment in patients with advanced ovarian cancer carrying BRCA mutations.

The granting of this priority review designation was based on positive results obtained from a Phase 3 clinical trial. The clinical trial results showed that, compared with placebo, olaparib demonstrated a statistically significant and clinically meaningful improvement in invasive disease-free survival (iDFS), reducing the risk of invasive breast cancer recurrence, new tumor occurrence, or death by 42% (HR=0.58; 99.5% CI 0.41-0.82; p<0.0001). In terms of safety, the safety and tolerability profile of olaparib was consistent with the findings observed in previous clinical trials. The trial data have been published in The New England Journal of Medicine.

References:

[1] LYNPARZA® (olaparib) Granted Priority Review in the US for BRCA-Mutated HER2-Negative High-Risk Early Breast Cancer. Retrieved November 30, 2021, from https://www.businesswire.com/news/home/20211130005457/en

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