FTSE 100: AstraZeneca breast cancer drug gets EU backing
AstraZeneca (AZN.L) said on Monday its Enhertu and Lynparza drugs have been recommended for approval in the European Union for patients with breast cancer.
According to the Anglo-Swedish drugs giant its Lynparza treatment has been recommended for marketing in the EU by the Committee for Medicinal Products for Human Use for early breast cancer treatment, after positive phase-three results.
It said the drug, a HER2-negative high-risk early breast cancer treatment, had demonstrated "a statistically significant and clinically meaningful" improvement in invasive disease-free survival.
In the trial, Lynparza was shown to reduce the risk of invasive breast cancer recurrences, new cancers, or death by 42% compared to placebo.
It also showed an improvement in overall survival by lowering the risk of death by 32% versus placebo.
Shares in the FTSE 100 (^FTSE) firm fell 0.4% in afternoon trade on Monday in London.
Susan Galbraith, AstraZeneca's executive vice president of oncology R&D, said: "If approved, Lynparza will become a new targeted treatment option for patients with germline BRCA-mutated HER2-negative early breast cancer in Europe.
"By treating patients with curative-intent as early as possible in their disease, we hope to avoid life-threatening recurrence and give people more time with their loved ones."
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Separately, its Enhertu drug, a monotherapy for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer, had also received recommendation for use in the US following the Destiny-Breast03 trial.
If a tumour is considered to be "resectable" it means that it is able to be removed with surgery.
The drug has been jointly developed and commercialised by AstraZeneca and Daiichi Sankyo Co (4568.T).
Results of the trial showed AstraZeneca and Daiichi Sankyo's candidate reduced the risk of disease progression or death by 72% compared with the trastuzumab emtansine drug.