Bayer announced that its collaboration partner Loxo Oncology, Inc. has completed the rolling submission of a New Drug Application (NDA) to FDA for larotrectinib for the treatment of adult and pediatric patients with locally advanced or metastatic solid tumors harboring a neurotrophic tyrosine receptor kinase (NTRK) gene fusion.
The rolling submission was initiated in Dec. 2017. NTRK gene fusions are genetic alterations present across a wide range of tumors resulting in uncontrolled tropomyosin receptor kinase (TRK) signaling and tumor growth.
“This NDA submission in the U.S. marks an important milestone in bringing us one step closer to providing larotrectinib as a potential treatment option for patients with TRK fusion cancer,” said Scott Fields, MD, Bayer’s senior vice president and head of Oncology Development at Bayer’s Pharmaceutical Division. “NTRK gene fusions, while rare, are present in various pediatric and adult cancers. We are committed to working with the FDA and the oncology community to bring larotrectinib to patients as soon as possible.”
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 a NTRK gene fusion. Bayer plans to submit a Marketing Authorization Application (MAA) in the European Union in 2018.
Filed Under: Drug Discovery