Treatment + Care

Approval of first tumor-agnostic therapy in Europe

Approval of first tumor-agnostic therapy in Europe marks meaningful advancement in cancer care

In a major milestone for cancer care in Europe, the European Commission has approved a first-of-its-kind precision oncology therapy. This therapy is exclusively designed for the treatment of adults and children with locally advanced or metastatic solid tumors that have a rare genomic alteration called an NTRK gene fusion, regardless of their age or tumor type. It is the first ever therapy in the E.U. to receive a tumor-agnostic indication.

This European approval was based on results from the global clinical trial program involving patients in research centres across Europe, including in the UK, Austria, France, Germany, Ireland, Italy, Spain, Denmark, Portugal and Sweden. The product is already approved in the U.S., Brazil and Canada.

What does this approval mean for patients with TRK fusion cancer in Europe?

Prior to this approval, those with TRK fusion cancer would have been treated based on where in the body their tumor is located. This first-ever tumor-agnostic drug approval means physicians in Europe can now treat adults and children with TRK fusion cancer of all ages, including those with primary CNS tumors and brain metastases, with a precision oncology treatment that is specifically developed to target the underlying cause of their cancer’s growth and spread.

Widely used, less-targeted cancer treatments currently used in the EU have limited efficacy and benefit in children and adults with TRK fusion cancer and can be poorly tolerated by patients.

Children with TRK fusion cancer in particular have been shown to benefit from this precision oncology therapy, regardless of their age. It can allow patients to avoid disfiguring surgery, such as amputation which can have devastating, life-long consequences.

What is TRK fusion cancer and how many people does it affect in Europe?

TRK fusion cancer is ultra-rare, affecting only a few thousand patients across Europe per year. It affects both children and adults and occurs in varying frequencies across various tumor types, including lung, thyroid, melanoma, gastrointestinal stromal tumors, colon, soft tissue sarcomas, salivary gland and infantile fibrosarcoma.

TRK fusion cancer is caused by a genomic alteration, occurring when a neurotrophic tyrosine receptor kinase (NTRK) gene fuses with another, unrelated gene. This alteration leads to an overexpression of TRK fusion proteins, which can cause the growth and spread of the tumor.

How would a patient know if they have TRK fusion cancer and may potentially benefit from precision oncology therapy?

The only way that a patient would know if they have TRK fusion cancer is through having their cancer properly tested for an NTRK gene fusion.

Europe’s leading medical cancer organisation, the European Society of Medical Oncology (ESMO) recently published recommendations on the routine detection of targetable NTRK gene fusions as part of everyday cancer care. These recommendations underline the importance of high-quality testing to help patients with cancer of all types to know whether they may potentially benefit from precision oncology therapy.

As we move towards a future where many more cancers will be treated based on the genomic alteration that is driving the tumor growth rather than where the tumor is sited, access to comprehensive, high-quality tests will be increasingly important.

To see how precision oncology therapies can benefit patients, read Kerstin’s inspiring story here: