Boehringer Ingelheim has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion for their non-small cell lung cancer drug nintedanib in combination with docetaxel.
The opinion has been issued on the combination for the treatment of patients with advanced non-small cell lung cancer (NSCLC) of adenocarcinoma histology after first line chemotherapy.
The CHMP’s positive opinion is now referred to the European Commission (EC), which grants marketing authorisation for medicines in the European Union. If approved, nintedanib will be the first triple angiokinase inhibitor licensed for the treatment of second-line adenocarcinoma of the lung. Nintedanib is an investigational agent and is not currently licensed in the UK.
Dr Yvonne Summers, Consultant Medical Oncologist from The Christie NHS Foundation Trust, said: “Given that lung cancer is the second most common cancer in the UK, this recommendation for European approval is promising news for patients and clinicians managing this disease.”
The CHMP positive opinion is based on the international, randomised, double-blind, placebo-controlled, Phase III LUME-Lung 1 trial which compared nintedanib plus docetaxel to placebo plus docetaxel in patients with locally advanced/metastatic or recurrent NSCLC after failure of first-line therapy.
Around 43,000 new lung cancer cases are diagnosed each year, making it the second most common cancer in the UK. NSCLC is the most common type of lung cancer, accounting for around 72% of all cases in England and Wales with adenocarcinoma being the most common histology.
Lung cancer is the leading cause of cancer mortality, accounting for more than a fifth of all cancer deaths in the UK.
Zinta Krumins, Managing Director of Boehringer Ingelheim Ltd in the UK said, “The CHMP’s positive opinion for nintedanib is good news for patients, their families and their doctors. Lung disease, from asthma and COPD to lung cancer, is a specific interest for Boehringer Ingelheim. This is our second lung cancer medicine and an important milestone for our future”.