Boehringer Ingelheim Pharmaceuticals, Inc. announced that the US Food and Drug Administration (FDA) has approved Gilotrif  (afatinib) tablets for oral use, as a new first-line (initial) treatment for patients with metastatic non-small cell lung cancer (NSCLC) with common epidermal growth factor receptor (EGFR) mutations as detected by an FDA-approved test. Discovered and developed by Boehringer Ingelheim, Gilotrif  is the first FDA-approved oncology product from the company.

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 per cent of Caucasians and approximately 40 per cent of Asians have EGFR mutations – which in 90 per cent of cases are one of the two most common EGFR mutations (Del19 or L858R).

“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, M.D., vice president, Clinical Development and Medical Affairs, Oncology. “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.”

To determine if a patient is eligible for Gilotrif , physicians must conduct a test for genetic mutations – also known as biomarker testing – to determine if a common EGFR mutation is present. For this reason, and in line with FDA’s current guidance, BI collaborated with QIAGEN, a leading global provider of sample and assay technologies, on the development of a companion diagnostic for Gilotrif . QIAGEN’s therascreen EGFR RGQ PCR Kit was reviewed and approved by the FDA in parallel to Gilotrif  and will be used to identify patients who may be eligible for treatment.

“We are truly excited to be able to offer Gilotrif  as a new treatment option for these patients. This approval is an achievement for Boehringer Ingelheim Oncology and the many teams and individuals who committed themselves to developing this therapy based on its potential identified in the clinical trial programme,” said Kevin Lokay, vice president and business unit head, Oncology, Boehringer Ingelheim Pharmaceuticals, Inc. “Gilotrif  marks the first, of what we expect will be many, oncology products to emerge from our research and development programme.”

The approval of Gilotrif  was supported in part by the LUX-Lung 3 trial – one of the largest phase III trials conducted to date in the first-line EGFR mutation-positive, locally advanced or metastatic NSCLC treatment setting.

Results showed that within the general study population, in the Gilotrif  arm, median progression-free survival (PFS) was 11.1 months versus 6.9 months for the chemotherapy arm (pemetrexed/cisplatin) (p<0.001).1 Approximately 90 per cent of patients in the study had the most common EGFR mutations (Del19 and L858R). In these patients, the median PFS in the Gilotrif  arm was 13.6 months versus 6.9 months in the chemotherapy arm.

In the LUX-Lung 3 trial, the most common drug-related adverse events (AEs) observed with Gilotrif  were diarrhea (96%), rash/dermatitis acneiform (90%), stomatitis (71%), paronychia (58%), dry skin (31%), decreased appetite (29%) and pruritus (21%).1 Serious adverse events (SAEs) were reported in 29 percent of patients treated with Gilotrif ; the most frequent SAEs were diarrhea (6.6%); vomiting (4.8%); and dyspnea, fatigue, and hypokalemia (1.7% each).1

Gilotrif  is indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumours have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test.

Building on scientific expertise and excellence in the fields of pulmonary and cardiovascular medicine, metabolic disease, neurology, virology and immunology, Boehringer Ingelheim has embarked on a major research programme to discover and develop innovative cancer treatments. The company is the largest US subsidiary of Boehringer Ingelheim Corporation and a member of the Boehringer Ingelheim group of companies.