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Boehringer's oncology unit scores first EU approval

Giotrif given green light for non-small cell lung cancer
Boehringer Ingelheim headquarters

Boehringer Ingelheim's push into cancer drug development a few years ago has borne its first fruit in Europe, with approval for non-small cell lung cancer (NSCLC) drug Giotrif.

The European Medicines Agency (EMA) has given a green light to Giotrif (afatinib) for the treatment of metastatic NSCLC patients whose tumours express the epidermal growth factor receptor (EGFR) and who have not previously received tyrosine kinase inhibitor (TKI) therapy.

The drug was approved for a similar indication in the US in July under the name Gilotrif and made its debut on the US market the following month, competing with TKI's such as AstraZeneca's Iressa (gefitinib) and Roche's Tarceva (erlotinib) for NSCLC, which was approved for first-line treatment of EGFR-positive NSCLC  in March. It has also been registered in Taiwan and Mexico.

Boehringer bills the new drug as the first irreversible ErbB family blocker to reach the market, noting that in trials it has been shown to delay tumour progression and improve disease-related symptoms compared to standard chemotherapy for NSCLC.

The drug's mode of action "allows afatinib to block EGFR and other members of the ErbB Family of receptors that play a key role in the growth and spread of cancers associated with a high mortality such as lung cancer", said Dr Sanjay Popat of the Royal Marsden NHS Foundation Trust in the UK, and lead investigator in Giotrif's pivotal trial.

Boehringer estimates that around 10-15 per cent of NSCLC patients are EGFR-positive in the US and EU, although the proportion increases to around 40 per cent in Asia. Boehringer has plans to extend the indications for Giotrif into breast and head and neck cancer.

Meanwhile, other companies are also vying to bring EGFR-targeting drugs to market for NSCLC, including Ariad Pharmaceuticals with its AP26113 candidate (in phase II) and Clovis Oncology with its CO-1686 (phase I).

Giotrif is one of one of three cancer drugs Boehringer is ushering through clinical development after it entered the cancer area in 2006.

The others are triple angiokinase inhibitor nintedanib, which is in phase III testing for NSCLC, ovarian cancer and idiopathic pulmonary fibrosis (IPF), and polo-like kinase 1 (Plk1) inhibitor volasertib, which is being developed to treat acute myeloid leukaemia.

Article by
Phil Taylor

27th September 2013

From: Sales

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