In July 2016, Loxo received breakthrough designation from the FDA for development of larotrectinib ( Loxo-101 ). The company discussed the path toward approval for this targeted drug with agency officials last summer, Bilenker told me. "Based on those discussions, we collected data prospectively for 55 patients with TRK fusion changes in the tumors," he said. "We think the data sufficient to support our filing for drug approval. We expect to submit the data to FDA by year end of 2017 or early 2018." Larotrectinib might be approved by mid-2018, he said.