The approval was given by the Japanese Ministry of Health, Labour, and Welfare after assessing the findings of Lynparza’s OlympiA Phase III study
AstraZeneca HQ in Cambridge UK. (Credit: D Wells from Wikipedia)
AstraZeneca and MSD have announced that Japanese authorities have approved the use of Lynparza (olaparib) as adjuvant treatment for patients with BRCA-mutated (BRCAm), HER2-negative early breast cancer.
The approval was given by the Japanese Ministry of Health, Labour, and Welfare after assessing OlympiA Phase III study findings.
The results of the study were published in The New England Journal of Medicine in June 2021. In the trial, Lynparza reduced risk of invasive breast cancer recurrences, new cancers, or death by 42% versus placebo.
It also demonstrated a statistically significant and clinically meaningful improvement in invasive disease-free survival (iDFS).
Additionally, Lynparza showed an improvement in overall survival lowering the risk of mortality by 32% compared to placebo.
In this experiment, Lynparza’s safety and tolerability profile matched the observations of earlier clinical trials.
AstraZeneca Oncology Business Unit executive vice-president Dave Fredrickson said: “Today’s approval marks a significant leap forward for breast cancer patients in Japan, where it is the most commonly diagnosed cancer among women.
“Patients with BRCA mutations have high rates of disease recurrence and lower survival, and Lynparza has been shown to significantly reduce both the risk of recurrence and death. We hope this approval sets a new, much-needed standard of care for these early breast cancer patients in Japan.”
AstraZeneca also announced the approval of its Tagrisso (osimertinib) in Japan for the treatment of patients with epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer post-surgery.
The company also announced the approval of Ultomiris (ravulizumab) in the country. The C5 complement inhibitor was approved treating adult patients with generalised myasthenia gravis (gMG) which are anti-acetylcholine receptor (AChR) antibody-positive and whose symptoms are difficult to control.