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.