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Boehringer's Giotrif wins new NSCLC licence in Europe

Can now be marketed for advanced squamous cell carcinoma of the lung
European Commission

Boehringer Ingelheim's Giotrif (afatinib) has widened its European licence after regulators approved the drug for a type of non-small cell lung cancer (NSCLC).

Giotrif was cleared by the European Commission to treat a sub-type of patients with advanced squamous cell carcinoma (SqCC) of the lung whose disease has progressed after chemotherapy treatment.

The approval was based on data from the LUX-Lung 8 trial, which is part of the largest clinical trial programme of EGFR tyrosine kinase inhibitors.

Giotrif reached its primary endpoint in the study of significantly delaying the progression of SqCC of the lung when compared against Roche/Astellas' Tarceva (erlotinib).

Overall survival was improved by 19% and allowed patients a better quality of life as well as greater control over their cancer symptoms.

Giotrif was first approved in Europe to treat NSCLC patients who have developed the EGFR mutation and its new licence makes it the first oral treatment for SqCC to be approved in the region.

Boehringer Ingelheim's Dr Medhi Shahidi, medical head, solid tumour oncology, said: “Whilst there have been some recent and significant advances in the treatment of squamous cell carcinoma of the lung, the intravenous administration and frequent visits to the hospital can be a challenge for patients often debilitated by this disease.

“In this context and supported by robust evidence from a global head-to-head phase III study, we are pleased to offer an effective oral treatment option for patients suffering from this type of lung cancer to the European market.”

SqCC of the lung accounts for approximately 20-30% of NSCLC cases and is associated with a poor prognosis, the median overall survival after diagnosis of advanced SqCC being around one year.

Giotrif joins several EGFR-targeting therapies on the market, including AstraZeneca's Tagrisso (omisertinib), Roche/Astellas' Tarceva and Bristol-Myers Squibb's Opdivo (nivolumab).

Article by
Rebecca Clifford

7th April 2016

From: Regulatory

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