- Health Canada has approved Lynparza (olaparib) as an adjuvant treatment for germline BRCA-mutated (gBRCAm), human epidermal growth factor receptor 2 (HER2)-negative high-risk early breast cancer.
- The approval is for patients who have been treated with neoadjuvant or adjuvant chemotherapy and confirmed germline BRCA mutation.
- The approval was based on the agency's accelerated review pathway and results from the OlympiA Phase III trial that showed a reduction in the risk of invasive breast cancer recurrences, second cancers or death by 42% compared to placebo.
- AstraZeneca ( NASDAQ: AZN ) and Daiichi Sankyo's ( OTCPK:DSKYF ) ( OTCPK:DSNKY ) Enhertu (trastuzumab deruxtecan) was recently approved by the U.S. FDA for HER2-low breast cancer .
For further details see:
AstraZeneca's Lynparza gains additional breast cancer indication in Canada