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  • Precision Oncology

First drug with tumor-independent indication approved

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  • 1 minute read

New paths are being taken in cancer therapy. Precision oncology opens up the possibility of tailoring treatment no longer to the localization of the tumor, but to its cross-tissue molecular genetic properties. Larotrectinib receives first tumor-independent approval.

The precision oncology drug larotrectinib (Vitrakvi®) can be used to treat adults and children with metastatic solid tumors that have a rare genomic alteration in tumor tissue called NTRK gene fusion. The novel and oral TRK inhibitor is the first member of a new class of drugs specifically designed for the treatment of tumors with NTRK gene fusion. NTRK gene fusions have been detected in over 20 different tumor entities to date. The oncogenic drivers are TRK protein kinases, which are highly selectively bound by the new compound. The approval is based on three multicenter, open-label, single-arm Phase I and II studies. The results show a high overall response rate of 79%. These could be detected across different tumor types (salivary gland carcinoma: 90%, lung carcinoma 75%, thyroid carcinoma 79%). The median duration of response across all patients was 35.2 months. Overall, Vitrakvi® also showed good tolerability: the majority of adverse events were grade 1 or 2. Efficacy was also seen in patients with TRK fusion tumors and brain metastases or primary CNS tumors, with a 75% response rate. The prerequisite for initiating the new therapy is the detection of an NTRK gene fusion.

Source: “Vitrakvi® (larotrectinib) receives first tumor-independent approval and offers new opportunities for cancer patients in Switzerland,” May 28, 2020, Bayer (Switzerland) Ltd.

 

InFo ONCOLOGY & HEMATOLOGY 2020; 8(3): 27.

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