Therapy Areas
Lynparza Receives Positive Opinion from EU CHMP as Adjuvant Treatment for Germline BRCA-Mutated, HER2-Negative High-Risk Early Breast Cancer
29 June 2022 - - The European Medicines Agency's Committee for Medicinal Products for Human Use has adopted a positive opinion recommending approval of Lynparza for the adjuvant treatment of patients with germline BRCA-mutated (gBRCAm), human epidermal growth factor receptor 2 -negative high-risk early breast cancer who have been treated with neoadjuvant or adjuvant chemotherapy, UK-based pharmaceutical company AstraZeneca and US-based Merck (NYSE: MRK) said.

The CHMP based its positive opinion on results from the Phase 3 OlympiA trial presented during the 2021 American Society of Clinical Oncology annual meeting and published in The New England Journal of Medicine in June 2021.

Breast cancer is the most commonly diagnosed cancer worldwide, with an estimated 2.3m patients diagnosed in 2020.

In the European Union, one in seven people who were assigned female at birth will develop breast cancer in their lifetime.

Approximately 75% of breast cancer patients worldwide are diagnosed with early breast cancer; however, a quarter of these patients will experience disease recurrence following surgery. In Europe, germline BRCA mutations are found in approximately 9% of patients.

In the trial, Lynparza demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of invasive disease-free survival, reducing the risk of invasive breast cancer recurrences, second cancers or death by 42% (HR=0.58 [99.5% CI, 0.41-0.82]; p
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