FDA Approves Treatment for Mantle Cell Lymphoma in Adults
The Priority Review program
The FDA also approved Calquence through its Priority Review program, which expedites the application process and reduces the drugs approval timeline from the standard 10 months to 6 months. The FDA reserves this expedited program for drugs that would significantly improve the outcomes of serious illnesses if approved. Such improvements can be demonstrated in several different ways, including evidence of increased effectiveness in treatment, which is the case for Calquence.
