Two AstraZeneca breast cancer drugs get European Community Committee OK

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Two AstraZeneca breast cancer drugs received positive recommendations for use in the European Union.

AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) has been recommended for approval in the EU  for the treatment of some adult patients with unresectable or metastatic (spreading)  HER2-positive breast cancer.

AstraZeneca and MSD’s (Merck in the U.S.)  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 HER2-negative high-risk early breast cancer.

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The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) based its positive opinion on results a late-stage trial. In the trial, Enhertu reduced the risk of disease progression or death by 72%.

Approximately one in five cases of breast cancer are considered HER2-positive.  Despite initial treatment with trastuzumab, pertuzumab and a taxane, patients with HER2-positive metastatic breast cancer will often see the disease progress. 

Susan Galbraith, executive vice president, Oncology R&D, AstraZeneca, said: “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.”

Enhertu is also being assessed in a comprehensive clinical development program evaluating efficacy and safety across multiple HER2-targetable cancers, including breast, gastric, lung, and colorectal cancers.

Lynparaza received a positive recommendation from the   CHMP committee of the European Medicines Agency based its positive opinion on results from a late-stage trial.

In that trial, Lynparza reduced the risk of invasive breast cancer recurrences, new cancers, or death by 42% versus placebo.

Lynparza also demonstrated an improvement in overall survival, reducing the risk of death by 32% versus placebo.

Breast cancer is the most diagnosed cancer worldwide with an estimated 2.3 million patients diagnosed in 2020. Approximately 90% of all breast cancer patients are diagnosed with early breast cancer.  

Professor Andrew Tutt, global chair of the OlympiA Phase III trial and professor of oncology at The Institute of Cancer Research, London and King’s College London, said: “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. 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.”

In March 2022, Lynparza was approved in the US for the treatment of gBRCAm, HER2-negative high-risk early breast cancer. 

Lynparza is also approved in the US, EU, Japan, and many other countries for the treatment of some patients with gBRCAm, HER2-negative, metastatic breast cancer who were previously treated with chemotherapy.

AstraZeneca employs 1,500 in Delaware.

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