Bayer seeks EU approval for TRK fusion cancer therapy

TRK gene fusions are a rare genetic alteration appearing across a range of tumours like lung, breast and colorectal cancer, melanoma and infantile fibrosarcoma, which result in uncontrolled TRK signalling and tumour growth. Larotrectinib (LOXO-101), for the treatment of patients with locally advanced or metastatic solid tumours that harbour an NTRK gene fusion, is an investigational tropomyosin receptor kinase inhibitor being jointly developed by Loxo and Bayer.  It is currently being reviewed by the FDA, and a decision should be made towards the end of this year. Now Bayer is also seeking marketing approval for its TRK fusion cancer therapy in the EU.

Ulrik Lassen, Department of Oncology, Rigshospitalet, said: “Larotrectinib has demonstrated exciting clinical responses in patients with TRK fusion cancer across various tumour types in both children and adults. The regulatory submission of larotrectinib in Europe moves us closer to being able to provide a targeted treatment option to these patients for which there is currently no approved therapy.”