Enhertu: EU regulator recommends lung cancer drug

AstraZeneca said on Friday its and Daiichi Sankyo’s cancer drug Enhertu was recommended by the European Medicines Agency’s human medicines committee as a monotherapy to treat patients with a type of non-small cell lung cancer (NSCLC).

The recommendation is based on the mid-stage data that showed Enhertu reduced the tumour by 49% and the median duration of response by 16.8 months in patients previously treated for lung cancer.

Recommendations made by the human medicines committee will have to be formally approved by the European Commission.

Lung cancer is the second most common form of cancer globally with more than two million cases diagnosed in 2020.1 In Europe, lung cancer is the third most commonly diagnosed cancer with more than 477,000 cases diagnosed in 2020.2 Lung cancer is also the leading cause of cancer-related deaths in Europe, with nearly 400,000 deaths reported in 2020.2 Prognosis is particularly poor for patients with metastatic NSCLC as only approximately 9% will live beyond five years after diagnosis.

HER2 is a tyrosine kinase receptor growth-promoting protein expressed on the surface of many types of tumours, including lung, breast, gastric and colorectal cancers. Certain HER2 (ERBB2) gene alterations (called HER2 mutations) have been identified in patients with non-squamous NSCLC as a distinct molecular target, and occur in approximately 2-4% of patients with this type of lung cancer

The medicine Enhertu (5.4mg/kg) is approved in more than 50 countries for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received a (or one or more) prior anti-HER2-based regimen either in the metastatic setting, or in the neoadjuvant or adjuvant setting and have developed disease recurrence during or within six months of completing therapy.