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 where Enhertu showed a confirmed objective response rate of 49% and a median duration of response of 16.8 months in patients previously treated for lung cancer.
The drug is already approved in the European Union as a treatment for patients with an advanced form of breast cancer.
Recommendations made by the human medicines committee will have to be formally approved by the European Commission.