EU panel backs Enhertu for certain breast cancers

LONDON - AstraZeneca PLC (LON:AZN) and Daiichi Sankyo’s Enhertu has been recommended for approval by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA). This recommendation is for the use of Enhertu as a monotherapy in adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-low or HER2-ultralow breast cancer who have previously undergone at least one endocrine therapy.

The CHMP’s positive opinion draws from the DESTINY-Breast06 Phase III trial results, which indicated a significant improvement in median progression-free survival (PFS) for patients treated with Enhertu compared to those receiving chemotherapy. Specifically, Enhertu demonstrated a 38% reduction in the risk of disease progression or death and a median PFS of 13.2 months versus 8.1 months for chemotherapy.

This recommendation marks a potential shift in treatment options for patients with HR-positive, HER2-low or HER2-ultralow metastatic breast cancer in the EU, directly following endocrine therapy. The safety profile of Enhertu in the trial was consistent with previous studies, presenting no new safety concerns.

Enhertu, a HER2-directed antibody drug conjugate (ADC), has already been approved in over 75 countries, including the EU and the US, for other indications related to metastatic breast cancer. The current approval process in the EU, along with reviews in Japan and several other countries, is based on the DESTINY-Breast06 trial outcomes.

The trial’s results were initially presented at the 2024 American Society of Clinical Oncology (ASCO) Meeting and later published in The New England Journal of Medicine. AstraZeneca (NASDAQ:AZN) and Daiichi Sankyo’s joint development and commercialization of Enhertu highlights the ongoing efforts to improve treatment outcomes for various types of breast cancer. The recommendation by the CHMP is based on a press release statement from AstraZeneca.

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