Boehringer’s lung cancer drug gets EMA nod

pharmafile | September 29, 2014 | News story | Sales and Marketing Boehringer, IPF, docetaxel, ingelheim, lung cancer, nintedanib 

The EMA has issued a positive opinion for the approval of Boehringer Ingelheim’s nintedanib in combination with docetaxel for the treatment of lung cancer, following trials suggesting they can increase overall survival by more than a year.

The Phase III LUME-Lung 1 trial tested the two drugs combined for the treatment of patients with an advanced form of the non-small cell lung cancer (NSCLC) adenocarcinoma after first-line chemotherapy.

Adenocarcinoma is the most common type of lung cancer and accounts for nearly half of all NSCLC cases. The majority of advanced adenocarcinoma patients will experience disease progression after first-line chemotherapy.

The trial showed that adding nintedanib to docetaxel extended the median overall survival from 10.3 to 12.6 months in patients, compared to docetaxel alone. Although this is only an improvement of two months, it makes nintedanib the first lung cancer treatment to demonstrate an overall survival rate of more than a year for patients with advanced adenocarcinoma.

Dr Martin Reck, head of department of thoracic oncology at Lung Clinic Grosshansdorf in Germany, says: “Patients with advanced adenocarcinoma NSCLC after first-line chemotherapy typically have a very poor prognosis. Therefore, providing an extension of overall survival while maintaining quality of life remains the ultimate goal. Nintedanib has shown promise in achieving this.”

In a statement Boehringer adds: “There is still a significant unmet need for new, effective second-line treatments for these patients who have a poor prognosis.”

Drug in other settings

Nintedanib is also tipped to potentially make a big splash in the emerging idiopathic pulmonary fibrosis (IPF) market. There is currently only one drug on the market in Europe for this fatal lung disease – InterMune’s Esbriet (pirfenidone) – but the drug has recently been accepted for accelerated review for its treatment by both the EMA and the FDA. It could be on the market from early 2015.

The cancer-blocking pill is also undergoing Phase III studies for the treatment of forms of colon cancer and ovrarian cancer, as well as Phase II studies in mesothelioma, kidney cancer and liver cancer.

George Underwood

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