Boehringer Ingelheim files first oncology compound, afatinib, for EU approval

German family-owned drug major Boehringer Ingelheim said yesterday that it has submitted a Marketing Authorization Application to the European Medicines Agency for approval of its first oncology compound, afatinib, the first irreversible ErbB Family Blocker, as a treatment for patients with EGFR (ErbB1) mutation positive non-small cell lung cancer (NSCLC).

Assuming it gains regulatory approval, afatinib would enter a global market valued at $4.3 billion in 2009 and set to growt to $6.9 billion in 2019. The company says that afatinib has demonstrated unprecedented efficacy versus chemotherapy in the Phase III LUX-Lung 3 registration trial, which provides pivotal support for this submission. The drug is also in Phase III trials for breast and head and neck cancer.

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. Around 20%-30% of all lung adenocarcinomas harbor EGFR mutations. Because of its poor prognosis, about 340,000 deaths each year in Europe are attributed to lung cancer, making it the most common cause of cancer death.