Proactive Investors - AstraZeneca PLC (LON:AZN) has announced that its jointly developed lung cancer drug has been approved for use in the European Union.
Enhertu, which has been co-developed with Daiichi Sankyo, received the green light for use in patients with advanced non-small cell lung cancer, whose tumours have an activating HER2 mutation.
The drug can be used as a monotherapy for patients who require systemic therapy following platinum-based chemotherapy, AstraZeneca said in a statement.
“With today’s news, Enhertu is the first antibody-drug conjugate approved for lung cancer in the EU and is now approved in three different tumour types,” oncology business head Ken Keller said.
In trial, Enhertu had demonstrated a confirmed response rate of 49% in those with previously treated metastatic HER2-mutant lung cancer.
“HER2-mutant non-small cell lung cancer is more commonly diagnosed in patients who are younger and female,” German oncology department head Martin Reck added.
"There are limited treatment options which often results in a poor prognosis.
“Enhertu is the first HER2-directed therapy to demonstrate strong and durable results for these patients, and this EU approval marks an important step forward in how the disease can be treated.”