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Home Industry News Boehringer Ingelheim’s Giotrif recommended for EU approval

Boehringer Ingelheim’s Giotrif recommended for EU approval

1st March 2016

Boehringer Ingelheim has announced that its drug Giotrif has been recommended for EU approval as a treatment for advanced lung cancer.

The European Medicines Agency's Committee for Medicinal Products for Human Use has issued a positive opinion for the approval of Giotrif for the treatment of patients with advanced squamous cell carcinoma of the lung, whose disease has progressed on or after treatment with platinum-based chemotherapy.

Data from the head-to-head LUX-Lung 8 trial showed that the drug can delay the progression of lung cancer and significantly improve overall survival rates among those affected by this disease, as well as improving quality of life and helping to control cancer symptoms.

LUX-Lung 8 is part of the broader LUX-Lung programme, which represents the largest collection of clinical trials to date of any EGFR tyrosine kinase inhibitor. More than 3,760 patients have been enrolled across the eight studies.

Dr Mehdi Shahidi, medical head of solid tumour oncology at Boehringer Ingelheim, said: "Not only does it represent the potential availability of the first oral treatment option specifically approved for patients with squamous cell lung cancer, it also confirms the positive profile of afatinib … when compared to a first-generation agent."

The drug is already approved for the treatment of patients with EGFR-mutated non-small cell lung cancer.ADNFCR-8000103-ID-801813733-ADNFCR

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