Bayer announced its collaboration partner Loxo Oncology has initiated the submission of a rolling New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) forlarotrectinib. The NDA is being submitted for the treatment of unresectable or metastatic solid tumors with NTRK-fusion proteins in adult and pediatric 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 harboring tropomyosin receptor kinase (TRK) gene fusions, which are genetic alterations present across a wide range of tumors resulting in uncontrolled TRK signaling and tumor growth. Loxo Oncology expects to complete the NDA submission in early 2018.
"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 pediatric tumors," said Carsten Brunn, president of Bayer Pharmaceuticals for the Americas Region. "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."
Larotrectinib (LOXO-101) is an investigational oral and selective drug in clinical development for the treatment of patients across a wide range of cancers that harbor abnormalities involving the tropomyosin receptor kinases (TRKs). Growing research suggests that the NTRK genes, which encode for TRKs, can become abnormally fused to other genes, resulting in growth signals that can lead to cancer in many sites of the body.
Larotrectinib has been granted Breakthrough Therapy Designation, Rare Pediatric Disease Designation and Orphan Drug Designation (ODD) by the FDA. Larotrectinib has not been approved by the FDA, the European Medicines Agency or any other health authority.
In November 2017, Bayer and Loxo Oncology entered into an exclusive global collaboration on the development and commercialization of larotrectinib and LOXO-195, a next-generation TRK inhibitor in clinical development. Bayer and Loxo Oncology will jointly develop the two products, larotrectinib and LOXO-195, and Bayer will lead ex-U.S. regulatory activities as well as worldwide commercial activities. In the U.S. Bayer and Loxo Oncology will co-promote the products. Loxo Oncology will remain responsible for the filing in the U.S.