Benzinga | Nov 30, 2021 04:44PM EST

AstraZeneca-Merck's Lynparza Under FDA Priority Review For Breast Cancer Setting

The FDA has granted priority review for AstraZeneca Plc's (NASDAQ:AZN) supplemental marketing application for Lynparza (olaparib) for breast cancer. The application for Lynparza covers the adjuvant treatment of patients with BRCA-mutated (BRCAm) HER2-negative high-risk early breast cancer who have already been treated with chemotherapy either before or after surgery.

* Lynparza is being jointly developed and commercialized by AstraZeneca and Merck & Co Inc (NYSE:MRK).

* The FDA action date for their regulatory decision is in Q1 of 2022.

* The application was based on results from the OlympiA Phase III trial presented during the 2021 American Society of Clinical Oncology Annual Meeting and simultaneously published in The New England Journal of Medicine.

* The results showed Lynparza demonstrated a statistically significant and clinically meaningful improvement in invasive disease-free survival, reducing the risk of invasive breast cancer recurrence, second cancers, or death by 42% versus placebo.

* Lynparza is approved in the US, EU, Japan, and several other countries to treat patients with germline BRCAm, HER2-negative, metastatic breast cancer previously treated with chemotherapy.

* See here Benzinga's Full FDA Calendar.

* Price Action: AZN shares are down 0.14% at $55.45, MRK stock is down 0.44% at $74.56 during the premarket session on the last check Tuesday.