Enhertu, a key drug from Daiichi Sankyo and AstraZeneca, continues to rapidly expand its market presence, having reached annual sales of $5 billion. The drug has received approval from the US Food and Drug Administration for the treatment of early breast cancer, further displacing Roche’s Kadcyla.
The FDA simultaneously approved Enhertu for neoadjuvant and adjuvant treatment of HER2‑positive early breast cancer. The decision on adjuvant use came nearly two months ahead of schedule – the regulator had originally planned to deliver its verdict by July 7.
However, there is an important restriction for the adjuvant indication: patients who have already received Enhertu before surgery cannot continue therapy with the drug after surgery. In the adjuvant setting, Enhertu is approved for patients with HER2‑positive breast cancer who have residual invasive disease after treatment with trastuzumab and taxane-based therapy.
For neoadjuvant use, Enhertu is approved in combination with standard THP combination therapy (a taxane, Herceptin and Perjeta) for the treatment of stage II or III HER2-positive breast cancer.
The adjuvant approval was based on data from the Destiny-Breast05 trial, which showed that Enhertu reduced the risk of invasive disease recurrence or death by 53% compared with Roche’s Kadcyla. In the neoadjuvant setting, the Destiny-Breast11 trial showed that Enhertu followed by THP achieved a pathological complete response rate of 67.3%, significantly higher than the 56.3% seen with the standard regimen.
The new label expansion will hit Roche’s Kadcyla hard. After losing ground to Enhertu in the metastatic setting, Kadcyla had been counting on adjuvant use as a source of further US sales growth.
Enhertu sales continue to rise as the drug moves into earlier lines of treatment. Combined sales from AstraZeneca and Daiichi Sankyo grew 31% in the first quarter of 2026, reaching 1.4billion. For the 2026 financial year ending in March 2027, Daiichi forecasts global Enhertu sales of 861.3 billion yen (1.4 billion. For the 2026 financial year ending in March 2027, Daiichi forecasts global Enhertu sales of 861.3 billion yen (5.4 billion). The drug remains a key element of Daiichi’s five‑year plan, which targets revenue of over 3 trillion yen by the 2030 financial year.
In Russia, there are currently no full analogues of Enhertu. In 2025, Russian drugmaker Biocad filed a lawsuit against AstraZeneca Pharmaceuticals LLC (AstraZeneca’s Russian subsidiary) in the Moscow Arbitration Court, accusing it of damaging its business reputation and disrupting clinical trials of an Enhertu analogue. According to Forbes, AstraZeneca representatives sent letters to hospitals and the Health Ministry criticising the development of the generic.
