Boehringer Ingelheim has won approval from the FDA for Gilotrif, or afatinib, as a treatment for patients with advanced squamous cell non-small cell lung cancer who experienced disease progression after platinum-based chemotherapy. The approval was granted based on late-stage trial data showing that afatinib decreased mortality and disease progression risk, compared with treatment with Tarceva, or erlotinib.
Bristol-Myers Squibb's PD-1 inhibitor nivolumab, or Opdivo, has been approved by the FDA for the treatment of non-small cell lung cancer in patients who fail to respond to platinum-based chemotherapy. The approval was made more than three months earlier than expected and about three months after the drugmaker submitted study data demonstrating Opdivo extended survival in patients with the disease. The drug is also approved for the treatment of advanced melanoma.
The FDA has approved the use of Eli Lilly's Cyramza, or ramucirumab, combined with docetaxel to treat patients with metastatic non-small cell lung cancer whose condition worsened after receiving platinum-based chemotherapy. The approval was based on data from a late-stage study that showed a ramucirumab-docetaxel combination therapy resulted in a better overall survival rate.
The European Commission approved Boehringer Ingelheim's Giotrif, or afatinib, for treatment of metastatic nonsmall-cell lung cancer involving certain types of EGFR mutations. The approval was based on data from a late-stage trial that showed afatinib improved progression-free survival compared with pemetrexed and cisplatin.
The FDA has approved Qiagen's Therascreen EGFR assay as a companion diagnostic to determine which patients are eligible to receive Boehringer Ingelheim's Gilotrif. Gilotrif, or afatinib, is a newly approved drug for patients with metastatic nonsmall-cell lung cancer who have exon 21 L858R substitution mutations and exon 19 deletions in the EGFR gene.