Boehringer Ingelheim is celebrating the approval of its first oncology drug after regulators in the USA gave the green light to Gilotrif for late-stage non-small cell lung cancer.
Specifically, the US Food and Drug Administration has approved Gilotrif (afatinib) for patients with metastatic NSCLC whose tumours express specific types of epidermal growth factor receptor (EGFR) gene mutations. These are detected by a companion diagnostic made by Qiagen (the therascreen EGFR RGQ PCR kit) which has also just been given the thumbs-up by the agency.
The FDA evaluated Gilotrif under its priority review programme and based its approval on a study of 345 participants with metastatic NSCLC whose tumours harboured EGFR mutations. Participants were randomly assigned to receive Gilotrif or up to six cycles of the chemotherapy drugs pemetrexed and cisplatin and the data showed that the Boehringer drug had a delay in tumor growth (progression-free survival) that was 4.2 months later than those receiving chemotherapy. There was no statistically significant difference in overall survival.
Lung cancer is the leading cause of cancer-related death and 85% of cases are NSCLC. EGFR gene mutations are present in about 10% of NSCLC, with the majority of these expressing EGFR exon 19 deletions or exon 21 L858R substitution, which Gilotrif, a tyrosine kinase inhibitor, specifically targets. The Qiagen test is the result of a collaboration with Boehringer that dates back to 2009.
The approvals "further illustrate how a greater understanding of the underlying molecular pathways of a disease can lead to the development of targeted treatments,” said Richard Pazdur, director of the Office of Hematology and Oncology Products at the FDA’s Center for Drug Evaluation and Research. He noted that gilotrif is the second drug approved this year for patients with untreated metastatic NSCLC whose tumours have the EGFR exon 19 deletions or exon 21 L858R substitution mutations.
In May, the agency gave the green light to Roche's Tarceva (erlotinib) for first-line treatment of patients with NSCLC, approved concurrently with the cobas EGFR Mutation Test.