EU Approves Enhertu for All HER2-Positive Solid Tumours in Landmark Ruling
1h ago|4 min readStandard
Fazen Markets Editorial Desk
Collective editorial team · methodology
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Fazen Markets Editorial Desk
Collective editorial team · methodology
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The European Commission granted a landmark tumour-agnostic marketing authorization for Daiichi Sankyo and AstraZeneca's antibody-drug conjugate Enhertu (trastuzumab deruxtecan) on 29 June 2026. This decision approves the drug for treating adult patients with unresectable or metastatic HER2-positive solid tumours who have received prior systemic therapy and have no satisfactory treatment options. The approval marks the first time a HER2-targeted therapy has received a broad, histology-independent clearance in the European Union, following a positive recommendation from the European Medicines Agency's Committee for Medicinal Products for Human Use earlier in the year.
The latest approval fundamentally broadens Enhertu's addressable patient population. Prior to this decision, Enhertu’s EU label was restricted to specific HER2-positive breast, gastric, and lung cancers. The closest comparable event was the US Food and Drug Administration's accelerated approval of Enhertu for HER2-positive solid tumours in April 2024, which served as a key precedent for the pan-tumour approach. The European approval now solidifies this regulatory pathway and expands it to a market of nearly 450 million people. The decision arrives as healthcare systems face escalating oncology costs, placing a premium on therapies that demonstrate efficacy across multiple tumour types with a single development program.
The macro backdrop includes sustained pressure on pharmaceutical pricing and a push for value-based care frameworks across Europe. The approval was triggered by compelling results from the Phase II DESTINY-PanTumor02 trial. That study demonstrated an objective response rate of 37.1% and a median duration of response of 11.8 months across a basket of seven different HER2-expressing solid tumour types, providing the clinical evidence required for a tumour-agnostic label.
Daiichi Sankyo and AstraZeneca reported Enhertu's global sales reached $7.12 billion for the full fiscal year ending 31 March 2025, a 45% increase year-over-year. The drug's peak sales potential is now estimated by consensus analyst forecasts to exceed $12 billion annually. In the DESTINY-PanTumor02 trial, the confirmed objective response rate (ORR) was 37.1% (95% CI: 29.5, 45.3), with a complete response rate of 4.5%. The median progression-free survival (PFS) was 6.9 months across all cohorts.
| Tumour Cohort | ORR in DESTINY-PanTumor02 |
|---|---|
| Biliary Tract Cancer | 22.2% |
| Bladder Cancer | 39.0% |
| Cervical Cancer | 50.0% |
| Endometrial Cancer | 57.5% |
| Ovarian Cancer | 45.0% |
| Pancreatic Cancer | 4.0% |
| Other Cancers | 30.0% |
For comparison, the current standard-of-care chemotherapy in these later-line settings typically yields response rates below 15%. AstraZeneca's oncology portfolio grew 18% in 2025, significantly outpacing the 7% growth of the broader pharmaceutical sector index (DRG). Daiichi Sankyo’s oncology revenue now constitutes over 60% of its total pharmaceutical sales.
The primary beneficiaries are the developers, Daiichi Sankyo (4568.T) and AstraZeneca (AZN.L, AZN), who share profits from Enhertu. The expanded label protects the drug’s revenue stream from biosimilar competition expected for older HER2 therapies in the late 2020s. Second-order gains extend to diagnostic companies like Agilent Technologies (A) and Roche (ROG.SW), which supply HER2 testing kits, as demand for comprehensive tumour profiling will rise. Contract research organizations (CROs) like ICON plc (ICLR) and Laboratory Corporation of America Holdings (LH) also stand to benefit from increased clinical trial activity in the tumour-agnostic space.
A key limitation is the drug's significant toxicity profile, including the risk of interstitial lung disease, which may restrict its use in broader patient populations. The high cost of therapy, estimated at over $15,000 per treatment cycle, also presents a reimbursement hurdle in cost-conscious European markets. Market positioning shows institutional investors have been net buyers of Daiichi Sankyo shares, with a 22% increase in foreign ownership over the past 12 months. Short interest in competing oncology-focused biotechs with narrower pipeline assets has risen by approximately 15%.
The next major catalysts are regulatory decisions in other key markets. Japan's Pharmaceuticals and Medical Devices Agency (PMDA) is expected to review the tumour-agnostic application by Q4 2026. Health Canada’s decision is anticipated in early 2027. Investors will monitor the conversion of the FDA's accelerated approval in the US to a full traditional approval, with a PDUFA date likely in 2027.
Key levels to watch include Daiichi Sankyo's ability to maintain its operating profit margin above 30% amid increased commercialisation expenses for the new indication. For AstraZeneca, the contribution of Enhertu to its total oncology sales, currently near 35%, will be a critical metric. If combined sales from the new indication exceed $1.5 billion in the first 12 months post-launch, it would signal faster-than-expected market penetration.
Tumour-agnostic or histology-independent approval means a drug is approved based on a specific biomarker, like HER2 positivity, regardless of where in the body the cancer originated. This represents a shift from organ-specific treatment to a molecularly guided approach. For patients, it opens a targeted therapy option for rare cancers where large clinical trials are not feasible. It accelerates drug development by allowing a single trial across multiple tumour types to support a broad label.
Enhertu is an antibody-drug conjugate, which delivers a potent chemotherapy payload directly to HER2-positive cells. This mechanism leads to significantly higher response rates in metastatic settings compared to older monoclonal antibodies like trastuzumab (Herceptin) or pertuzumab. In HER2-positive metastatic breast cancer, Enhertu demonstrated a median PFS of 28.8 months versus 7.2 months for physician's choice of therapy in the DESTINY-Breast04 trial. Its efficacy in tumours with low HER2 expression, where Herceptin is ineffective, is a key differentiator.
The EU approval directly expands the eligible patient pool by tens of thousands annually. Analysts project the tumour-agnostic label could add $2 to $3 billion in incremental peak sales to Enhertu's franchise. For Daiichi Sankyo, Enhertu is the cornerstone of its oncology ambitions and funds its extensive R&D pipeline. For AstraZeneca, the drug solidifies its position as a top-tier oncology company and helps offset upcoming patent expiries for other key drugs like Tagrisso later in the decade.
The EU’s tumour-agnostic approval reshapes the commercial and clinical landscape for HER2-targeted cancer therapy, securing Enhertu's long-term dominance.
Disclaimer: This article is for informational purposes only and does not constitute investment advice. CFD trading carries high risk of capital loss.
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