Boehringer gets EU nod for nintedanib in lung cancer

Boehringer Ingelheim’s nintedanib has been cleared in the EU to treat lung cancer, just a few weeks after a green light in the US to treat pulmonary fibrosis.

The European Medicines Agency (EMA) approved nintedanib as Vargatef as a second-line treatment in combination with docetaxel for patients with advanced adenocarcinoma, the most common form of non-small cell lung cancer (NSCLC).

The approval is based on the results of the 1,300-patient LUME-Lung 1 trial, which showed that adding nintedanib to docetaxel in these patients improved overall survival by more than a year, according to oncologist Martin Reck of Lung Clinic Grosshansdorf in Germany, who said the drug represented “a much-needed new treatment option.”

Nintedanib is described as a triple angiokinase inhibitor, targeting receptors for three growth factors – vascular endothelial growth factor (VEGF), platelet-derived growth factor (PDGF) and fibroblast growth factor (FGF) – that are thought to be involved in the formation of blood vessels in tumours.

The drug was cleared by the FDA last month as Ofev to treat the progressive lung disease pulmonary fibrosis and has just been recommended for approval in this indication in Europe, giving Boehringer an entry into another market predicted to reach several billion dollars in the coming years.

The EU approval is another major milestone for Boehringer’s ambitions in oncology, a therapeutic category it only entered with the launch of irreversible ErbB blocker Giotrif/Gilotrif (afatinib) for NSCLC last year.

Afatinib and nintedanib are the first two drugs to emerge from an R&D programme set up by the privately-held German firm back in 2006. A third candidate – polo-like kinase 1 (Plk1) inhibitor volasertib – is in Phase III testing as a treatment for acute myeloid leukaemia (AML).

In addition to lung cancer, nintedanib is also in Phase III testing for colorectal and ovarian cancer, as well as Phase II trials for mesothelioma, kidney cancer and liver cancer. Earlier this year, Boehringer said it was entering a new growth phase with 10 new product launches scheduled by 2016.

Lung cancer is the leading cause of cancer death worldwide, killing nearly 1.6 million people worldwide each year, according to the International Agency for Research on Cancer, although there are a raft of new therapies coming through development that promise to improve the effectiveness of treatment.

In addition to nintedanib, Eli Lilly’s ramucirumab has shown promising activity in NSCLC in Phase III, while the new PD-1/PD-L1 inhibitor class – headed by Merck & Co’s Keytruda (pembrolizumab) and Bristol-Myers Squibb’s Opdivo (nivolumab) – are also expected to be important new treatment options in this form of cancer.


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