What is AstraZeneca (NASDAQ:AZN) and Daiichi Sankyo's latest move with Enhertu?

AstraZeneca and Daiichi Sankyo have advanced their application to the European Medicines Agency (EMA) to expand Enhertu’s use as a monotherapy for early-stage HER2-positive breast cancer patients who still have invasive disease after surgery. The submission triggers a formal review by the EMA’s Committee for Medicinal Products for Human Use (CHMP).

How does Enhertu compare to the current treatment for early-stage HER2-positive breast cancer?

Enhertu reduced the risk of disease recurrence or death by 53% compared to Roche's Kadcyla, the current standard of care. This significant improvement suggests Enhertu may become the preferred option for high-risk patients who do not fully respond to initial treatments.

What does the validation from the EMA mean for Enhertu?

The EMA's validation of AstraZeneca and Daiichi Sankyo's application means that Enhertu will undergo a formal scientific review by the EMA’s CHMP. If approved, this would significantly expand Enhertu's market and potential as a treatment for high-risk early-stage breast cancer.

What are the potential risks and rewards for investors in AstraZeneca and Daiichi Sankyo?

The expansion of Enhertu's approval could drive significant revenue growth for both companies if it becomes a treatment of choice for high-risk early-stage breast cancer. However, the approval process is still ongoing, and future regulatory hurdles or competition from other therapies could pose risks.

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AstraZeneca, Daiichi Sankyo gain key EU review for Enhertu in early breast cancer

Written by Brie CarterPublished Feb 19, 2026, 12:00 AMLast Updated Jul 6, 2026, 10:45 AM

AstraZeneca (NASDAQ:AZN) and Daiichi Sankyo moved a step closer to expanding the use of their blockbuster cancer therapy, Enhertu, into the curative-intent setting for early-stage breast cancer.

The European Medicines Agency (EMA) validated the companies’ application for Enhertu as a monotherapy for adults with HER2-positive breast cancer who still have invasive disease after receiving initial treatment and undergoing surgery.

The validation triggers a formal scientific review by the EMA’s Committee for Medicinal Products for Human Use (CHMP).

The submission is backed by data from the DESTINY-Breast05 Phase 3 trial, which showed Enhertu reduced the risk of disease recurrence or death by 53% compared to the current standard of care, Roche Holding AG’s Kadcyla (T-DM1).

The results, first presented at the ESMO 2025 Congress and published in the New England Journal of Medicine, underscore Enhertu's potential to become the preferred option for high-risk patients who fail to achieve a complete response after pre-surgical (neoadjuvant) therapy.

Enhertu, an antibody-drug conjugate (ADC) designed to deliver a high-potency payload directly to cancer cells, has already transformed the treatment of metastatic breast cancer.

The companies are currently pursuing several other regulatory paths in the EU, including a first-line metastatic indication in combination with pertuzumab and a "tumor-agnostic" label for all HER2-positive solid tumors.