Tumor-Agnostic Cancer Advance
Enhertu Gains EU Approval as First Tumor-Agnostic HER2-Positive Cancer Therapy
Key Points
In DESTINY-PanTumor02, Enhertu achieved a confirmed objective response rate of 52.3% across a broad range of HER2-positive tumors (including biliary tract, bladder, cervical, endometrial, ovarian and pancreatic cancers), with a median duration of response of 21.1 months and a safety profile consistent with prior trials.
EU approval triggers a $25 million milestone payment to Daiichi Sankyo, reinforcing the partners' ongoing collaboration and illustrating the financial milestones tied to Enhertu's expanded EU footprint.
Benedikt Westphalen highlighted the potential shift in cancer care, noting that HER2 overexpression occurs across multiple tumour types and that HER2-directed therapies were historically limited to specific tumor types, underscoring the significance of a tumour-agnostic approach.
In DESTINY-Lung01, the HER2-positive NSCLC subgroup demonstrated an objective response rate ranging from 27.8% to 77.0%, with a median duration of response of about 6.9 months, illustrating meaningful activity across different assessment cohorts.
The European Commission has approved Enhertu as the first tumor-agnostic HER2-directed therapy in the EU, according to AstraZeneca. The drug, developed by AstraZeneca and Daiichi Sankyo, can now treat adults with any unresectable or metastatic HER2-positive solid tumor — regardless of where in the body it started — as long as prior treatments have failed.
The decision, announced June 29, 2026, expands Enhertu's EU label to six cancer indications. It triggers a $25 million milestone payment from AstraZeneca to Daiichi Sankyo, Market Screener reported. Shares in AstraZeneca rose 0.25% on the London Stock Exchange within minutes of the announcement.
How One Drug Now Treats Six Types of Cancer
Before this approval, cancer drugs were almost always tied to one organ — breast, lung, stomach. Enhertu breaks that mold. It targets a protein called HER2. When a tumor overproduces HER2, Enhertu can attack it, no matter where the tumor is. This approach is called "tumor-agnostic" treatment.
Dr. Benedikt Westphalen, Head of Precision Oncology at the University of Munich, called it a turning point. HER2 overexpression is linked to "aggressive disease and a poor prognosis," he said, according to Mirage News. This approval "opens a new treatment option... regardless of where the tumor originated." The drug now covers breast, lung, gastric, bladder, biliary tract, and several other cancer types.
Trial Data That Convinced European Regulators
The European Commission based its decision on three Phase II trials. The strongest results came from DESTINY-PanTumor02. In that study, Enhertu achieved a 52.3% confirmed response rate across patients with biliary tract, bladder, cervical, endometrial, ovarian, and pancreatic cancers. Responses lasted a median of 21.1 months, according to AstraZeneca.
The colorectal cancer trial, DESTINY-CRC02, showed a 46.9% response rate with a median duration of 5.5 months. In the lung cancer trial, DESTINY-Lung01, the HER2-positive subgroup showed response rates ranging from 27.8% to 77.0%. Grade 3 or 4 serious side effects occurred in 18.5% of patients across the pooled data. Fatal lung inflammation was seen in about 1% of cases, TipRanks noted.
A Milestone Payment and a Blockbuster Revenue Story
The approval is worth real money immediately. AstraZeneca must pay Daiichi Sankyo $25 million as a contractual milestone. Daiichi Sankyo will also continue to book sales across most EU territories. Analysts at TipRanks maintained a "Buy" rating on AstraZeneca, with price targets reaching £180. The drug is seen as a key pillar in AstraZeneca's goal of hitting $80 billion in total revenue by 2030.
Ken Keller, Daiichi Sankyo's Global Head of Oncology, called it a "significant milestone" that makes Enhertu the first ADC — antibody-drug conjugate — to earn a pan-cancer approval in Europe, according to Market Screener. Dave Fredrickson, AstraZeneca's Oncology chief, said the approval lets doctors consider the drug across "multiple additional tumor types" and underscored the need for broader HER2 testing.
Approval Does Not Mean Instant Access for All Patients
EU-wide approval is a legal green light, not a guarantee of access. Reimbursement decisions vary by country. Germany's system works very differently from Poland's. Patient advocates warn that many European patients could wait months or years before the drug reaches them at an affordable cost, according to Mirage News.
There is also a testing gap. The approval only covers tumors with high HER2 overexpression — classified as IHC 3+. Cancers like biliary tract and endometrial are not routinely tested for HER2 today. That means hospitals across Europe will need to scale up diagnostic testing quickly to find eligible patients. Roche, which makes HER2 diagnostic tools, stands to benefit from this shift, Guru Focus reported.
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