- 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 EMA’s 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.
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EMA validates change to Daiichi Sankyo's application for lung cancer drug Enhertu