26 March 2018 - Bayer today announced that its collaboration partner Loxo Oncology has completed the rolling submission of a new drug application to the U.S. FDA for larotrectinib for the treatment of adult and paediatric patients with locally advanced or metastatic solid tumors harbouring a neurotrophic tyrosine receptor kinase gene fusion. 

The rolling submission had been initiated in December 2017. Neurotropic tyrosine kinase gene (NTRK) fusions are genetic alterations present across a wide range of tumours resulting in uncontrolled tropomyosin receptor kinase (TRK) signaling and tumour growth. Larotrectinib was designed to directly target TRK, turning off the signaling pathway that allows TRK fusion cancer to grow.

Bayer and Loxo Oncology are jointly developing larotrectinib, an investigational compound being studied globally for the treatment of patients across a wide range of cancers that harbor an NTRK gene fusion. Bayer plans to submit a marketing authorisation application in the European Union in 2018.

Read Bayer press release