EU-approved cancer drugs by tumour and biomarker

oncolabels is a free reference of the indications the European Union has approved for cancer drugs. It covers 604 indications of 187 targeted, immune and hormone drugs, without classic chemotherapy. Each indication is split into tumour, biomarker, cut-off, line of therapy and regimen, next to the sentence of the label it comes from. It is a non-commercial reference for education and research, for anyone who needs to know what the EU labels say, such as pathologists, oncologists and researchers.

Yes, all of it. Two AI models read every label separately and a third decided where they differed. At this time no person reviews the entries; a human review stage may be added later. If you spot an error, flag it with Report a problem on the indication or with Feedback at the bottom of any page.

Search for the tumour and the biomarker together, for example HER2 gastric cancer. oncolabels lists every EU-approved indication that fits, with the line of therapy, the combination and the conditions the label sets. Each tumour has its own page, such as non-small cell lung cancer, and so does each biomarker and each drug.

From section 4.1, Therapeutic indications, of each drug's summary of product characteristics (SmPC), the EU label that the European Medicines Agency (EMA) publishes. oncolabels checks EMA's data every day and reads a label again when it changes. Each entry quotes the label's wording and links to the SmPC.

The summary of product characteristics (SmPC) is the approved product information of a drug authorised in the EU, written for healthcare professionals. Section 4.1 states the therapeutic indications: the disease, the patients, any biomarker requirement and the line of therapy the drug is approved for. Use outside these indications is off-label.

Each indication shows the biomarker it requires and the cut-off, as the label states them. The What to test list on each tumour page gathers every biomarker that decides at least one approval in that tumour, with the usual test method, for example for colorectal cancer.

They are the scoring systems for PD-L1 immunohistochemistry. TPS is the percentage of viable tumour cells with membrane staining. CPS is the number of stained tumour cells, lymphocytes and macrophages per 100 viable tumour cells. IC is the share of the tumour area covered by stained immune cells. Each label sets its cut-off in one of them. Pembrolizumab alone in first-line non-small cell lung cancer needs a TPS of at least 50%, and in the second line at least 1%. The PD-L1 page lists every cut-off.

An approval for a molecular alteration wherever the tumour started, for example an NTRK gene fusion in any solid tumour. The EU has approved 6 tumour-agnostic indications, listed on the tumour-agnostic page. oncolabels also shows them on each tumour's page, because they apply whenever the tumour carries the alteration.

A marketing authorisation granted by the European Commission on the EMA's recommendation is valid in all 27 EU member states and in Iceland, Liechtenstein and Norway. The United Kingdom is no longer part of this system. Its regulator, the MHRA, authorises drugs there, and UK labels can differ.

The EMA assesses drugs for the EU and the US Food and Drug Administration (FDA) for the United States, each on its own. An indication approved in the US may not be approved in the EU, may come later or may be worded differently, for example with another biomarker cut-off. oncolabels covers EU approvals only.

No. The approval allows the drug to be marketed for the stated indications. Whether and when it is available and paid for is decided in each country, for example after the benefit assessment by the G-BA in Germany.

The What's new page lists the drugs first approved in a period you choose and every change to the labels in it, from new indications to safety updates, in the words of EMA's record. Each drug's page also shows its label history.

oncolabels checks EMA every morning and reads a label again when it changes. The last check was on 5 Nov 2026, and the data last changed on 5 Nov 2026. Every page shows the day of the last check. The methods page shows how each entry was made.

oncolabels is made by Tillmann Bedau, a pathologist in Germany, as a non-commercial project for education and research. It gives no medical advice, and you use it at your own risk. The current SmPC takes precedence over anything shown here. Contact details are in the legal notice, and the terms of use set out the rest.

Yes. oncolabels has an MCP server that Claude, ChatGPT and other assistants can connect to, and a JSON API with the same lookups. Both are free and need no key. The data is also available as JSON and CSV under the CC BY 4.0 licence.