Bayer’s collaboration partner Loxo Oncology has initiated the submission of a rolling new drug application (NDA) for larotrectinib (LOXO-101) to the US Food and Drug Administration (FDA).
Larotrectinib is an oral selective compound under assessment for the treatment of cancers harbouring tropomyosin receptor kinase (TRK) gene fusions that lead to uncontrolled TRK signalling and tumour growth.
The NDA seeks indication for treating resectable or metastatic solid tumours with NTRK-fusion proteins in adults and paediatrics who progressed after previous therapy or do not have acceptable alternative treatments and require systemic therapy.
Loxo Oncology estimates to complete the submission early next year.
The FDA previously granted larotrectinib with breakthrough therapy, rare paediatric disease and orphan drug designations.
Bayer Pharmaceuticals Americas president Carsten Brunn said: “Research has generated great interest in TRK as a potential target for cancer treatment because while TRK fusions occur rarely, they present broadly in various rare adult and paediatric tumours.
“We are pleased with the initiation of the rolling NDA submission for larotrectinib which brings us one step closer to potentially providing a treatment option for these patients.”