AstraZeneca and Merck Receive CHMP Positive Opinion of Lynparza (olaparib) as Adjuvant Treatment for HER2-Negative High-Risk Early Breast Cancer
- The EMA’s CHMP has adopted a positive opinion recommending the approval of Lynparza for gBRCAm, HER2- high-risk early breast cancer
- The opinion was based on the P-III (OlympiA) trial which showed an improvement in the 1EPs of IDFS with a 42% reduction in risk of invasive breast cancer recurrences, second cancers, or death along with an improvement in the key 2EPs of OS with 32% reduction in risk of death. The safety & tolerability was consistent with prior clinical trials
- Additionally, ~10% of patients discontinued treatment due to an AR. Lynparza was approved in the US for gBRCAm, HER2- high-risk early breast & is also approved in the US, EU, Japan & multiple other countries for gBRCAm, HER2- metastatic breast cancer
Ref: Bussinesswire | Image: AstraZeneca
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