Analysts view Boehringer Ingelheim's first move into cancer drug market

German family-owned drug major Boehringer Ingelheim last month announced the submission of a Marketing Authorization Application (MAA) to the European Medicines Agency for the approval of afatinib, its first anti-cancer drug candidate (The Pharma Letter September 21).

This regulatory milestone brings afatinib a step closer to becoming available to patients with advanced and metastatic non-small cell lung cancer (NSCLC) harboring EGFR mutations, note analysts at industry expert GlobalData. Afatinib, if approved, will be a direct competitor to currently available EGFR tyrosine kinase inhibitors Tarceva and Iressa. What differentiates afatinib is that it is an irreversible ErbB family inhibitor of EGFR (ErbB1), HER2 (ErbB2) and ErbB4, whereas Tarceva and Iressa are reversible inhibitors that target EGFR only.

GlobalData estimates the global NSCLC therapeutics market is currently worth approximately $5 billion and is forecast to reach $9.5 billion by 2018. Notably, AstraZeneca's $500 million drug Iressa (gefitinib) and Roche's $1 billion drug Tarceva (erlotinib) are key market players. However, sales for Tarceva also include use for pancreatic cancer. Boehringer Ingelheim is also trying to test the drug’s potential to treat other cancer patient populations. Afatinib has reached Phase III clinical development in breast cancer and head and neck cancer, and if the results of these trials are positive, Boehringer Ingelheim will seek further approvals.