Larotrectinib (trade name: Vitrakvi) has been approved in Germany since September 2019 for the treatment of all solid tumors with NTRK (neurotrophic tyrosine receptor kinase) gene fusions.
An NTRK gene fusion results from the "joining together" of an NTRK gene with another gene. This causes too many cells to grow. Larotrectinib aims to inhibit the overactive gene product that is responsible in order to slow down the growth of the cancer.
Larotrectinib can be used in the form of a solution or capsules. Adults take 100 mg twice daily. The dose for children is based on their body surface area. A gastric (stomach) tube or nasogastric tube (through the nose) can also be used to deliver the drug. The treatment is stopped if severe side effects arise or if the cancer progresses.
Best supportive care (BSC) is the standard treatment for advanced cancer in adults and children if there is no other suitable treatment or surgery. This treatment should be tailored to the patient’s individual needs, relieve symptoms such as pain, and improve their quality of life.
In 2019 the Institute for Quality and Efficiency in Health Care (IQWiG, Germany) wanted to find out whether larotrectinib has any advantages or disadvantages for the treatment of advanced cancer with NTRK gene fusions compared to treatment with BSC.
The manufacturer didn’t provide any data that could be used to draw conclusions about the pros and cons in the treatment of certain types of cancer. Also, the studies didn’t compare larotrectinib with BSC or another treatment. A direct or indirect comparison is needed in order to draw any conclusions about the advantages or disadvantages of a specific treatment compared to another treatment.
This information summarizes the main results of a review produced by the Institute for Quality and Efficiency in Health Care (IQWiG, Germany). The review was commissioned by the German Federal Joint Committee (G-BA) as part of the “early benefit assessment of medications.” On the basis of the review and the hearings received, the G-BA passed a resolution on the added benefit of larotrectinib (Vitrakvi).
Institute for Quality and Efficiency in Health Care (IQWiG, Germany). Larotrectinib (solid tumors with NTRK gene fusion) – Benefit assessment according to §35a Social Code Book V. Dossier assessment; Commission A19-90. January 13, 2020. (IQWiG reviews; Volume 866).
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