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AstraZeneca and MSD’s Lynparza (olaparib) Receive EC’s Approval as Adjuvant Treatment for Germline BRCA-Mutated HER2-Negative High-Risk Early Breast Cancer

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AstraZeneca and MSD’s Lynparza (olaparib) Receive EC’s Approval as Adjuvant Treatment for Germline BRCA-Mutated HER2-Negative High-Risk Early Breast Cancer

AstraZeneca and MSD’s Lynparza (olaparib) Receive EC’s Approval as Adjuvant Treatment for Germline BRCA-Mutated HER2-Negative High-Risk Early Breast Cancer

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  • The approval was based on the P-III (OlympiA) trial evaluating the efficacy & safety of 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, and an improvement in OS with a 32% reduction in risk of death. The safety & tolerability profile of Lynparza was consistent with that observed in prior trials
  • Lynparza was approved in the US for gBRCAm, HER2- high-risk early breast & was also approved in the US, EU, Japan & multiple other countries for gBRCAm, HER2- metastatic breast cancer

Ref: AstraZeneca | Image: AstraZeneca

Click here to­ read the full press release 

Neha

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.

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