Boehringer’s Gilotrif approved by FDA for metastatic NSCLC
The FDA has announced today that it approves Boehringer's Gilotrif (afatinib) for the treatment of patients with late stage (metastatic) non-small cell lung cancer (NSCLC) whose tumors express specific types of epidermal growth factor receptor (EGFR) gene mutations, as detected by an FDA-approved Qiagen diagnostic test.
The decision follows the approval of Roche's Tarceva (erlotinib) for first-line treatment of patients with NSCLC when used concurrently with a companion diagnostic test.
Related news:
FDA approval for Boehringer means fast competition to Roche's targeted Tarceva (FiercePharma)
Reference links:
FDA approves new treatment for a type of late-stage lung cancer (Press release)