Loxo Oncology announces submission of European marketing authorisation application for larotrectinib

Loxo Oncology

27 August 2018 - Loxo Oncology today announced that its collaboration partner, Bayer, has submitted a marketing authorisation application for larotrectinib to the EMA. 

Larotrectinib is being investigated to potentially treat adult and paediatric patients with locally advanced or metastatic solid tumors with a neurotrophic tyrosine receptor kinase (NTRK) gene fusion.

Loxo Oncology and Bayer are engaged in a collaboration for the development and commercialisation of larotrectinib. In May 2018, larotrectinib was granted priority review by the U.S. FDA for the treatment of adult and paediatric patients with locally advanced or metastatic solid tumours harbouring an NTRK gene fusion. The FDA has set a target action date of 26 November 2018, under the Prescription Drug User Fee Act.

Read Loxo Oncology press release

Michael Wonder

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Michael Wonder

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Cancer , Medicine , Europe , Dossier