US- FDA Grants Priority Review for AstraZeneca/Merck’s sNDA for Lynparza (olaparib) as Adjuvant Treatment in BRCA-Mutated, HER2-Negative High-Risk Early Breast Cancer

AstraZeneca and Merck announced that a sNDA for Lynparza (olaparib) has been accepted and granted priority review by the FDA for the adjuvant treatment of patients with BRCA-mutated (BRCAm), human epidermal growth factor receptor 2 (HER2)-negative high-risk early breast cancer who have already been treated with chemotherapy either before or after surgery. The FDA has set a PDUFA, or target action, date during the 1Q-2022.

The sNDA was based on results from the Phase 3 OlympiA trial presented during the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting and simultaneously published in The New England Journal of Medicine.
These results showed Lynparza demonstrated a statistically significant and 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 (HR=0.58 [99.5% CI, 0.41-0.82]; p<0.0001).
The safety and tolerability profile of Lynparza in the OlympiA trial did not differ from that observed in prior clinical trials. The most common adverse events (AEs) (≥20%) were nausea (57%), fatigue (40%), anemia (23%) and vomiting (23%). Grade ≥3 AEs were anemia (9%), neutropenia (5%), leukopenia (3%), fatigue (2%) and nausea (1%). Approximately 10% of patients treated with Lynparza discontinued treatment due to AEs.

Link to press release 30-Nov-21