EMA Request Prompts Approval Delay for Advanced Accelerator Applications’ Lutathera

An EMA request prompted a delay in the review of Advanced Accelerator Applications’ marketing authorization application for its tumor therapy Lutathera.

The company said the agency requested clarifications that will prolong the review of the application. In addition to the clarifications, the EMA has asked to inspect one of the company’s contract research organizations.

In May, the EMA granted Lutathera an accelerated assessment, which is a designation given to treatments that meet major public needs and provide an innovative therapeutic option. A month later, the FDA awarded the drug priority review.