The European Commission (EC) has approved Daiichi Sankyo and AstraZeneca’s antibody-drug conjugate ENHERTU (trastuzumab deruxtecan) to treat advanced non-small cell lung cancer (NSCLC) patients with a HER2 mutation. 

Enhertu is already approved for patients with breast cancer– either HER2-positive or HER2-low, and HER2-positive gastroesophageal junction adenocarcinoma in the EU. The latest approval makes it the first antibody-drug conjugate approved to treat HER2+ NSCLC in the EU. 

GlobalData’s consensus forecast projects global sales for Enhertu to exceed $10.65bn by 2029. 

GlobalData is the parent company of Pharmaceutical Technology. 

The NSCLC approval follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) after clinical trial data was presented at the IASLC 2023 World Conference on Lung Cancer in September 2023. The data showed that Enhertu reduced tumours in 49% of patients in the trial.  

The Phase II DESTINY-Lung02 trial (NCT04644237), which drove the latest approval, evaluated the safety and efficacy of Enhertu to treat HER2 mutant metastatic NSCLC patients with disease recurrence or progression and those who need systemic therapy following platinum-based chemotherapy.  

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Subsequent to the latest EU approval, Daiichi Sankyo is entitled to receive a milestone payment of $75m from AstraZeneca. 

Daiichi Sankyo and AstraZeneca entered a development and commercialisation collaboration agreement for Enhertu in March 2019 with a $1.35bn upfront payment from AstraZeneca. 

AstraZeneca oncology executive vice-president Dave Fredrickson said: “Enhertu is the first HER2-directed option approved for HER2 mutant disease and confirms the relevance of HER2 as a target in lung cancer.” 

This content was updated on 25 January 2024