Home » FDA Grants Priority Review to Larotrectinib
FDA Grants Priority Review to Larotrectinib
Drugs Submissions and Approvals
The FDA granted its priority review designation to Bayer and Loxo Oncology for their cancer drug larotrectinib for tumors that have a rare mutation in common.
Bayer also plans to submit its EU marketing application for the drug this year. The FDA plans to decide on the marketing application by Nov. 26.
Analysts project annual sales of between $500 million and $1 billion.