AstraZeneca and MSD’s Lynparza (olaparib) Receive MHLW Approval as Adjuvant Treatment for BRCA-Mutated HER2-Negative High-Risk Early Breast Cancer
Shots:
- The approval was based on the P-III (OlympiA) trial evaluating Lynparza vs PBO in patients with gBRCAm, high-risk HER2- early breast cancer prior treated with neoadjuvant or adjuvant CT. The trial was sponsored by NRG Oncology in the US & by AstraZeneca outside the US
- The results showed an improvement in iDFS with a 42% reduction in risk of invasive breast cancer recurrences, new cancers, or death & improvement in OS with a 32% reduction in risk of death. The safety & tolerability profile was consistent with prior trials
- Lynparza was approved in the US for gBRCAm, HER2- high-risk early breast cancer, based on P-III (OlympiA) trial results & was approved in the US, EU, Japan & other countries for gBRCAm, HER2-, metastatic breast cancer
Ref: AstraZeneca | Image: AstraZeneca
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Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.
