Boehringer Ingelheim has officially entered the oncology space. The FDA approved the private company’s once-daily pill for metastatic non-small cell lung cancer (NSCLC) medication, Gilotrif, on Friday. The FDA gave the first-line oral cancer treatment orphan drug status and priority review.
Gilotrif (afatinib) is for a specific subset of patients: those with NSCLC who have epidermal growth factor receptor (EGFR) mutations. Although 85% of lung cancers are NSCLC, only around 10% of these patients have these specific mutations. The FDA also approved a companion diagnostic to identify this mutation on Friday—Qiagen’s Therascreen EGFR.
The BI/Qiagen approval may be familiar to oncology watchers. That’s because in May the FDA not only approved Roche’s Tarceva as a first-line treatment for this very same condition, but also approved Roche’s biomarker test to help identify patients who will benefit from the EGFR treatment.
Data supporting the FDA’s approval of BI’s new oncology drug included a clinical trial of 345 patients that showed a progression-free survival rate of 4.2 months longer than patients who received chemotherapy, although there was no statistical difference when it came down to overall survival rates.
The oral tyrosine kinase receptor inhibitor is BI’s first marketed cancer med. Also in Phase III are nintedanib, an oral triple angiokinase inhibitor that is also being tested in NSCLC and ovarian cancers.
