(CercleFinance.com) – Daiichi Sankyo announced Wednesday that the European Medicines Agency (EMA) has validated the type II quality change related to the approval of Enhertu in the treatment of non-small cell lung cancer.
The Japanese pharmaceutical laboratory specifies that this validation confirms that the registration application filed with EMA is now complete, which means that the agency’s Committee for Medicinal Products for Human Use (CHMP) will now be able to examine the dossier for authorization .
This question concerns the use of Enhertu as monotherapy in the treatment of unresectable or metastatic non-small cell lung cancer in patients with a HER2 mutation who have already received treatment.
Enhertu, an antibody drug jointly developed and marketed by Daiichi Sankyo and AstraZeneca, has already been approved for some indications, such as breast cancer.
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