Bayer has filed a marketing application in Europe seeking approval for larotrectinib as treatment for TRK fusion cancer.
NTRK gene fusions are genetic mutations resulting in the production of tropomyosin receptor kinase (TRK) fusion proteins and lead to the development of tumor growth.
Larotrectinib is an investigational tropomyosin receptor kinase (TRK) inhibitor being jointly developed by Bayer and Loxo.
“Larotrectinib has demonstrated exciting clinical responses in patients with TRK fusion cancer across various tumor types in both children and adults,” said Ulrik Lassen, Department of Oncology, Rigshospitalet, Copenhagen.
“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.”
The drug is also under review in the US, where a decision is expected by November 26.