Loxo Oncology and Bayer AG said the U.S. Food and Drug Administration granted priority review to their cancer drug and would decide on the marketing application by Nov. 26.
The drug, larotrectinib, is being developed for a wide variety of tumors that share a rare mutation, and analysts expect annual sales to reach $500 million to $1 billion.
Larotrectinib will now get a speedy review for adult and pediatric patients with locally advanced or metastatic solid tumors with a type of mutation called neurotrophic tyrosine receptor kinase (NTRK) gene fusion.
Bayer plans to submit the European Union marketing application for the drug this year, Loxo said.
(Reporting by Manas Mishra in Bengaluru; Editing by Sriraj Kalluvila)