Two drugs receive EU approval for treating some breast cancers


AstraZeneca, a multinational pharmaceutical & biotechnology company, has recently stated that its new drug Lynparza, developed in collaboration with Merck & Co., was suggested for treating some speculative breast cancers in the European Union (EU).

Similarly, Enhertu (developed jointly by Daiichi Sankyo and AstraZeneca) has also been suggested for authorization in the EU as a monotherapy for treating adult patients suffering from metastatic or unresectable HER2-positive breast cancer, which have earlier received one or more prior anti-HER2-based regimens.

Enhertu is an explicitly formulated HER2-directed ADC (antibody-drug conjugate) developed jointly and commercialized by AstraZeneca and Daiichi Sankyo.

The CHMP (Committee for Medicinal Products for Human Use) of the EMA (European Medicines Agency) has based its positive opinion on outcomes from the Phase III trial of the DESTINY-Breast03, which was published recently in The New England Journal of Medicine.

Enhertu, in the trial, lowered the risk of disease evolution or death by 72% as compared to trastuzumab emtansine (T-DM1) in patients with HER2-positive unresectable and/or metastatic breast cancer earlier treated with trastuzumab and a taxane.

It is critical to note that annually around 530,000 cases of breast cancer are diagnosed in Europe.

Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca, stated that this recommendation signifies the revolutionary progression-free survival benefits seen in the trial of DESTINY-Breast03 compared to T-DM1, supporting Enhertu to be a potentially new standard of care and creating a new benchmark for treating HER2-positive metastatic breast cancer.

If the European Commission approves, then the patients in Europe may be able to be benefitted from this vital medicine earlier for treating their disease, enhancing the chances for better results.

Furthermore, the recommendation is now expected to be reviewed by the European Commission, which has the authority to grant marketing approvals for medicines in the EU.

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