Boehringer Submits Afatinib to EMA

Boehringer Ingelheim announced earlier today that they have submitted their first oncology compound, afatinib, to European regulators.

The German firm filed a marketing authorisation application to the European Medicines Agency (EMA) for the approval of afatinib as a treatment for patients with EGFR (ErbB1) mutation positive non-small cell lung cancer (NSCLC).  Boehringer confirmed that afatinib has shown “unprecedented efficacy versus chemotherapy” in the Phase III LUX-Lung 3 study, which provides the basis for the submission.

Afatinib is the lead compound in a new class of cancer drugs known as irreversible ErbB family blockers and targets a genetic mutation that occurs in twenty to thirty per cent of patients with NSCLC.

Non-small cell lung cancer accounts for over 85% of the 391,000 lung cancer cases detected in Europe each year, and the cancer is linked with a very poor prognosis, causing 340,000 deaths every year, according to Boehringer.

The Phase III LUX-Lung 3 clinical trial compared afatinib to the best-in-class chemotherapy (pemetrexed and cisplatin) for nonsquamous non-small cell lung cancer 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 11.1 months without their tumour growing (progression-free survival) in comparison to 6.9 months on the chemotherapy combo.

More patients who took afatinib experienced an improvement in dyspnoea (shortness of breath), cough and chest pain and the medication also considerably postponed the worsening of these symptoms in comparison to chemotherapy.  A standard questionnaire asked of participants highlighted that treatment with afatinib resulted in a better quality of life.

Additional information from the trial, including symptom improvement and health-related quality of life results, will be presented at the European Society for Medical Oncology congress in Vienna at the end of the month.

Klaus Dugi, head of medicine at Boehringer, commented that “with so many people being diagnosed with, and dying from lung cancer, there is still a clear need for effective and tolerable therapies.” Dugi added that the positive clinical evidence for afatinib, “coupled with its novel mode of action, could make this an outstanding treatment option.”

Boehringer Ingelheim has also started two head-to-head trials (LUX-Lung 7 and 8) comparing afatinib to the presently available tyrosine kinase inhibitors, AstraZeneca’s Iressa and Roche’s Tarceva.  The drug is also currently in Phase III for breast cancer and head and neck cancer.

Afatinib is one of three cancer medications that Boehringer is currently steering through clinical development as they overhaul their R&D operations with a drive into new therapeutic categories, including cancer and diabetes.


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