AstraZeneca announced it had officially received recommendations for EU approval for its breast cancer treatments Enhertu and Lynparza on Monday.
The pharmaceutical giant reported the recommended approval of its Enhertu treatment for patients with HER2-positive metastatic breast cancer treated with a prior anti-HER2-based regimen, and the use of its Lynparza (olaparib) treatment for patients with germline BRCA-mutated HER-2-negative high-risk early breast cancer.
AstraZeneca confirmed Enhertu had been recommended for approval in the EU as a monotherapy for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who had previously received at least one previous anti-HER2-based regimen.
The drug was developed and commercialised by AstraZeneca and Daiichi Sankyo.
The approval recommendation was based off the positive results of the project’s DESTINTY-Breast03 Phase three trial, which indicated a 72% reduction in the risk of disease progression or death compared to trastuzumab emtansine in patients previously treated with trastuzumab and a taxane.
“This recommendation reflects the transformative progression-free survival benefit seen in the DESTINY-Breast03 trial compared to T-DM1, supporting Enhertu as a potential new standard of care and setting a new benchmark in the treatment of HER2-positive metastatic breast cancer,” said AstraZeneca executive vice president of oncology research and development Susan Galbraith.
“If approved by the European Commission, patients in Europe may be able to benefit from this important medicine earlier in the treatment of their disease, improving their chance for better outcomes.”
AstraZeneca’s Lynparza treatment has been recommended for marketing authorisation in the EU for adult patients previously treated with neoadjuvant chemotherapy.
The recommendation was based off results from the company’s OlympiA Phase three trial, which reportedly displayed a reduced risk of breast cancer recurrences, new cancers or death by 42% against a placebo.
The treatment also increased chances of survival overall, with a reduced risk of death by 32% compared to a placebo. The safety of the drug lined up with results in previous trials.
“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,” said OlympiA Phase three trial chair Professor Andrew Tutt.
“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.”