Two AstraZeneca Breast Cancer Drugs Gain European Community Committee Approval
Two AstraZeneca breast cancer drugs have received positive recommendations for use in the European Union.
Enhertu (trastuzumab deruxtecan) from AstraZeneca and Daiichi Sankyo has been recommended for approval in the EU for the treatment of certain adult patients with unresectable or metastatic (spreading) HER2-positive breast cancer.
AstraZeneca and MSD (Merck in the US) Lynparza (olaparib) has been recommended for marketing authorization in the EU for the adjuvant treatment of adult patients with germline BRCA1/2 mutations who have early breast cancer at high risk HER2 negative.
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has based its positive opinion on the results of a late-stage trial. In the trial, Enhertu reduced the risk of disease progression or death by 72%.
About one in five breast cancer cases is considered HER2 positive. Despite initial treatment with trastuzumab, pertuzumab, and a taxane, patients with HER2-positive metastatic breast cancer will often see disease progression.
Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca, said: “This recommendation reflects the transformative progression-free survival benefit observed in the DESTINY-Breast03 trial compared to T-DM1, supporting Enhertu as a new standard of potential care and setting a new benchmark in the treatment of HER2-positive metastatic breast cancer.
Enhertu is also being evaluated as part of a comprehensive clinical development program evaluating the efficacy and safety of several HER2-targeted cancers, including breast, stomach, lung and colorectal.
Lynparaza received a positive recommendation from the CHMP committee of the European Medicines Agency based on its positive opinion on the results of a late-stage trial.
In this trial, Lynparza reduced the risk of recurrence of invasive breast cancer, new cancers, or death by 42% compared to placebo.
Lynparza also demonstrated improved overall survival, reducing the risk of death by 32% compared to placebo.
Breast cancer is the most diagnosed cancer in the world with approximately 2.3 million patients diagnosed in 2020. About 90% of all breast cancer patients are diagnosed with early breast cancer.
Professor Andrew Tutt, Global Chairman of the Olympia Phase III trial and Professor of Oncology at the Institute of Cancer Research London and King’s College London, said: “For breast cancer patients at high risk at an early stage, the risk of recurrence remains too high and the cancer will return for more than one in four of these patients. Today’s recommendation is hopeful news for patients in Europe, as we move closer to establishing a potential new standard of care that improves overall survival for patients eligible for treatment with olaparib. .
In March 2022, Lynparza was approved in the United States for the treatment of gBRCAm, HER2-negative high-risk early breast cancer.
Lynparza is also approved in the United States, European Union, Japan and many other countries for the treatment of certain patients with gBRCAm, HER2-negative metastatic breast cancer who have previously been treated with chemotherapy.
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