EMA validates change to Daiichi Sankyo's application for lung cancer drug Enhertu
Professor25/iStock via Getty Images


Japanese pharmaceutical giant Daiichi Sankyo (OTCPK:DSKYF) (OTCPK:DSNKY) on Wednesday said Europe's drug regulator had validated a change to its application for lung cancer treatment Enhertu.
The European Medicines Agency (EMA) validated a Type II variation application for Enhertu as a monotherapy for the treatment of unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations and who have received a prior systemic therapy.

A Type II variation is a major change to an authorization that may have a significant impact on the safety or efficacy of a medicine, but does not involve a change to the medicine's active substance or route of administration.
"Validation confirms that the application is complete and commences the scientific review process by the EMAâs Committee for Medicinal Products for Human Use," Daiichi Sankyo said in a statement.
Enhertu is being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca (AZN).
The application for Enhertu was based on data from a two-part mid-stage trial called DESTINY.