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AstraZeneca PLC said on Monday that its breast cancer treatments, Lynparza and Enhertu, have been recommended for approval in the EU.
The Anglo-Swedish drugmaker said its Lynparza treatment has been recommended for approval in the European Union by the Committee for Medicinal Products for Human Use for early breast cancer treatment, after positive phase-three results.
Lynparza demonstrated a statistically significant and clinically meaningful improvement in overall survival, reducing the risk of death by 32% versus placebo, AstraZeneca said.
The drug is being jointly developed with US pharmaceutical firm Merck & Co Inc.
Separately, AstraZeneca said its Enhertu drug also has been recommended for approval in the EU for patients with breast cancer. This drug is being jointly developed with Japanese pharmaceutical company Daiichi Sankyo Co Ltd.
Data from a phase three trial showed that Enhertu reduced the risk of disease progression or death by 72% versus trastuzumab emtansine, another breast cancer treatment.
The recommendations will now be reviewed by the European Commission, which has the authority to grant marketing authorisations for medicines in the EU.
AstraZeneca and Daiichi Sankyo also submitted a supplemental new drug application to Japan's Ministry of Health, Labour & Welfare on Monday for another breast cancer drug, trastuzumab deruxtecan.
The application was based on phase three data in which the treatment demonstrated clinically meaningful efficacy in progression-free survival and overall survival.
Shares in AstraZeneca were up 0.1% at 10,789.80 pence on Monday morning in London while Daiichi Sankyo closed 0.3% higher at JP¥3,323.00 in Tokyo.
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