US FDA approves Boehringer Ingelheim's first cancer drug

In what the family-owned German drug major Boehringer Ingelheim hopes is just the first drug to come out of its own oncology research portfolio, the company on Friday (July 12) received approval from the US Food and Drug Administration to market its afatinib (to be called Gilotrif) as first-line treatment for metastatic non-small cell lung cancer (NSCLC) with common epidermal growth factor receptor (EGFR) mutations as detected by an FDA-approved test.

In some people, genetic mutations lead to the constant activation of the EGFR protein, which is associated with uncontrolled cell division and the development and progression of NSCLC. Among patients diagnosed with NSCLC (the most common form of lung cancer, it is estimated that between 10% and 15% percent of Caucasians and around 40% of Asians have EGFR mutations – which in 90% of cases are one of the two most common EGFR mutations (Del19 or L858R).[v]

“The approval of Gilotrif offers a new treatment option and provides a personalized treatment approach for patients with EGFR mutation-positive metastatic non-small cell lung cancer,” said Berthold Greifenberg, vice president, clinical development and medical affairs, oncology, at Boehringer. “Over the past decade, great progress has been made in understanding the biology of lung cancer and Gilotrif is an example of how, at BI, we are translating this knowledge into a new treatment option for patients,” he added.