CHMP recommends Lynparza as adjuvant treatment for patients with germline BRCA-mutated HER2-negative high-risk early breast cancer.-AstraZeneca + Merck Inc.,
AstraZeneca and MSD’s Lynparza (olaparib) has been recommended for marketing authorisation in the European Union (EU) as monotherapy or in combination with endocrine therapy for the adjuvant treatment of adult patients with germline BRCA1/2 mutations (gBRCAm) who have HER2-negative high-risk early breast cancer previously treated with neoadjuvant or adjuvant chemotherapy.
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency based its positive opinion on results from the OlympiA Phase III trial published in The New England Journal of Medicine in June 2021.(previously cited).In the trial, Lynparza demonstrated a statistically significant and clinically meaningful improvement in invasive disease-free survival (iDFS), reducing the risk of invasive breast cancer recurrences, new cancers, or death by 42% versus placebo (based on a hazard ratio [HR] of 0.58; 99.5% confidence interval [CI] 0.41-0.82; p<0.0001).lynparza also demonstrated a statistically significant and clinically meaningful improvement in overall survival (os), reducing the risk of death by 32% versus placebo (based on a hr of 0.68; 98.5% ci 0.47-0.97; p="0.009)." the safety and tolerability profile of lynparza in this trial was in line with that observed in prior clinical trials.></0.0001).lynparza>
Professor Andrew Tutt, Global Chair of the OlympiA Phase III trial and Professor of Oncology at The Institute of Cancer Research, London and King’s College London, said: “For patients with high-risk, early-stage breast cancer, the risk of recurrence remains unacceptably high and cancer will return for more than one in four of these patients. Today’s recommendation is hopeful news for patients in Europe, as we move closer to setting a potential new standard of care that improves overall survival in patients suitable for treatment with olaparib.”.
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