AstraZeneca/Merck's Lynparza gets approval in EU for expanded use in breast cancer subtype
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AstraZeneca (NASDAQ:AZN) and Merck's (NYSE:MRK) medicine Lynparza was approved for expanded use in treating certain patients with breast cancer in the EU.
The European Commission (EC) approved Lynparza (olaparib) as a standalone treatment or in combination with endocrine therapy as an adjuvant treatment of adult patients with germline BRCA1/2 mutations (gBRCAm), who have human epidermal growth factor receptor 2 (HER2)-negative high-risk early breast cancer, and who have been previously treated with neoadjuvant or adjuvant chemotherapy.

A panel of the European Medicines Agency (EMA) had recommended the approval of the drug in June.
The EC approval was backed by data from a phase 3 trial called OlympiA.
"With this approval, Lynparza is now the first and only PARP inhibitor available for patients with germline BRCA-mutated HER2-negative early breast cancer in Europe," said Dave Fredrickson, executive vice president, Oncology business unit, AstraZeneca (AZN).
AstraZeneca (AZN) noted that it will receive a regulatory milestone payment of $75M from Merck (MRK), following this approval. The amount is expected to be booked as Collaboration Revenue in Q3 2022.