Boehringer Ingelheim’s Giotrif gets Europan regulatory backing in another lung cancer indication
German drugmaker Boehringer Ingelheim on Thursday said European regulators have granted marketing rights for its non-small cell lung cancer (NSCLC) drug Giotrif (afatinib) to also be used as treatment for another indication in lung cancer.
The approval for the drug to treat squamous cell carcinoma (SqCC) was based on data from the LUX-Lung 8 trial, which is part of the largest clinical trial programme of EGFR tyrosine kinase inhibitors. The marketing authorisation in Europe is valid for 28 countries within the EU, the family-owned firm said.
The drug met its primary endpoint in the study of significantly delaying the progression of SqCC of the lung when compared against Roche/ Astellas’ Tarceva (erlotinib), the company said in a statement.
Overall survival improved by 19% and allowed patients a better quality of life as well as greater control over their cancer symptoms.
Mehdi Shahidi, medical head, solid tumour oncology, Boehringer Ingelheim says: “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.”
Giotrif is already approved for the treatment of patients with EGFR mutation-positive non-small cell lung cancer.
SqCC of the lung accounts for about 20-30% of NSCLC cases and is associated with a poor prognosis, the median overall survival after diagnosis of advanced SqCC is around one year.
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