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
