Boehringer Ingelheim has submitted its lung cancer drug afatinib for approval in Europe, marking the first major regulatory milestone in the firm's push into oncology R&D which got underway in 2006.
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 20 to 30 per cent of patients with non-small cell lung cancer (NSCLC).
The personalised medicine has been filed as a treatment for NSCLC patients who test positive for a mutation in the epidermal growth factor receptor (EGFR) called ErbB1 on the back of the LUX-Lung 3 trial, which compared afatinib to therapy with Eli Lilly's $2.2bn-a-year blockbuster Alimta (pemetrexed) plus cisplatin.
The study found that patients with advanced non-squamous NSCLC who were treated first-line with afatinib had 11.1 months of progression-free survival (PFS), compared to 6.9 months with Alimta and cisplatin, which is considered the best-in-class chemotherapy at present.
Moreover, patients with two of the most common ErbB mutations -del19 and L858R which account for 90 per cent of all EGFR-positive NSCLC cases - fared even better, with PFS reaching 13.6 months.
NSCLC accounts for more than 85 per cent of the 391,000 lung cancer cases diagnosed in Europe every year, and the cancer is associated with a very poor prognosis, causing 340,000 deaths a year, according to Boehringer.
"With so many people being diagnosed with, and dying from lung cancer, there is still a clear need for effective and tolerable therapies," commented Professor Klaus Dugi, Boehringer's corporate senior vice president, medicine.
"The positive clinical evidence for afatinib, coupled with its novel mode of action, could make [afatinib] an outstanding treatment option," he added.
The pharma company is carrying out comparative studies against other NSCLC products - notably AstraZeneca's Iressa (gefitinib) and Roche's Tarceva (erlotinib), which had sales of $554m and $564m, respectively, in 2011. The drug has also reached phase III in breast cancer and head and neck cancer.
Afatinib is one of three cancer drugs Boehringer is ushering through clinical development as it revamps its R&D operations with a push into new therapeutic categories including cancer and diabetes.
The other cancer candidates are angiogenesis inhibitor nintedanib, in phase III for NSCLC and ovarian cancer, and polo-like kinase 1 (Plk1) inhibitor volasertib which is in phase II testing for acute myeloid leukaemia.