Boehringer Ingelheim files MAA with EMA for afatinib approval

Published on September 20, 2012 at 5:49 AM · No Comments

Today, Boehringer Ingelheim has announced the submission of a Marketing Authorisation Application to the European Medicines Agency (EMA) for approval of afatinib, the first irreversible ErbB Family Blocker, as a treatment for patients with EGFR (ErbB1) mutation positive non-small cell lung cancer (NSCLC). Afatinib has demonstrated unprecedented efficacy versus chemotherapy in the Phase III LUX-Lung 3 registration trial, which provides pivotal support for this submission.   

NSCLC comprises over 85% of the 391,000 new cases of lung cancer diagnosed annually in Europe, with adenocarcinoma being the most common type of NSCLC. Approximately 20-30% of all lung adenocarcinomas harbour EGFR mutations. Because of its poor prognosis, approximately 340,000 deaths each year in Europe are attributed to lung cancer, making it the most common cause of cancer death.   

"With so many people being diagnosed with, and dying from lung cancer, there is still a clear need for effective and tolerable therapies. Boehringer Ingelheim is committed to helping patients have access to afatinib as soon as possible," said Prof. Klaus Dugi, Corporate Senior Vice President Medicine, Boehringer Ingelheim. "The positive clinical evidence for afatinib, coupled with its novel mode of action, could make this an outstanding treatment option, providing much needed benefits for lung cancer patients."

The submission is based on the comprehensive LUX-Lung clinical trial programme. Data from the pivotal LUX-Lung 3 trial, comparing afatinib to the best-in-class chemotherapy (pemetrexed and cisplatin) for nonsquamous NSCLC, demonstrated superiority in patients with stage IIIb or IV adenocarcinoma of the lung harbouring an EGFR mutation. Patients taking afatinib as a first-line treatment lived for almost one year without their tumour growing (progression-free survival (PFS) of 11.1 months) versus just over half a year (PFS of 6.9 months) for those on chemotherapy (pemetrexed / cisplatin). Furthermore, NSCLC patients with tumours harbouring the two most common EGFR mutations (del19 and L858R, accounting for 90% of all tumours with EGFR mutations) taking afatinib lived for well over a year without disease progression (PFS of 13.6 months) versus just over half a year (PFS of 6.9 months) for those in the comparator arm.

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