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AstraZeneca and Merck Receive CHMP Positive Opinion of Lynparza (olaparib) as Adjuvant Treatment for HER2-Negative High-Risk Early Breast Cancer

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AstraZeneca and Merck Receive CHMP Positive Opinion of Lynparza (olaparib) as Adjuvant Treatment for HER2-Negative High-Risk Early Breast Cancer

AstraZeneca and Merck Receive CHMP Positive Opinion of Lynparza (olaparib) as Adjuvant Treatment for HER2-Negative High-Risk Early Breast Cancer

Shots:

  • 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

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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