Posted by Michael Wonder on 21 Dec 2017
Bayer announces initiation of rolling submission of new drug application in the U.S. for larotrectinib for the treatment of TRK fusion cancers
20 December 2017 - Completion of NDA submission expected in early 2018.
Bayer today announced that its collaboration partner Loxo Oncology has initiated the submission of a rolling new drug application to the U.S. FDA for larotrectinib. The application is being submitted for the treatment of unresectable or metastatic solid tumours with NTRK-fusion proteins in adult and paediatric patients who require systemic therapy and who have either progressed following prior treatment or who have no acceptable alternative treatments.
Bayer and Loxo Oncology are jointly developing larotrectinib, an investigational compound being studied globally for the treatment of patients with cancers harbouring tropomyosin receptor kinase (TRK) gene fusions, which are genetic alterations present across a wide range of tumours resulting in uncontrolled TRK signalling and tumour growth.
