FDA Approves First Personalized Medicine for EGFR Mutation-Positive Metastatic Non-Small Cell Lung Cancer in the United States

May 14th, 2013

On May 14, 2013, the FDA approved Tarceva® (erlotinib) tablets for the initial (first-line) treatment of people with metastatic non-small cell lung cancer (NSCLC) whose tumors have been identified to have certain epidermal growth factor receptor (EGFR) mutations by an FDA-approved test.

The FDA also approved the cobas® EGFR Mutation Test, which was developed by Roche and validated in the pivotal EURTAC study.

News in brief

• Personalized option for initial treatment that helped metastatic NSCLC patients who tested positive for a specific EGFR mutation live longer without their disease worsening (median progression-free survival 10.4 months vs. 5.2 months in a Phase III study).
• Ten to 30 percent of people worldwide with lung cancer have tumors that test positive for certain EGFR mutations.
• Tarceva is already approved for people with advanced-stage NSCLC whose cancer has not spread or grown after initial treatment with certain types of chemotherapy (Maintenance treatment). Tarceva is also approved for people with advanced-stage NSCLC whose cancer has spread or grown after receiving at least one chemotherapy regimen (Second/Third-line treatment).

Indications

• Tarceva is prescribed for patients with metastatic non-small cell lung cancer (NSCLC) whose cancer has been identified to have certain Epidermal Growth Factor Receptor (EGFR) mutations by an FDA-approved test (first-line treatment).
• Tarceva is prescribed for patients with advanced-stage NSCLC whose cancer has not spread or grown after initial treatment with certain types of chemotherapy (maintenance treatment).
• Tarceva is prescribed for patients with advanced-stage NSCLC whose cancer has spread or grown after receiving at least one chemotherapy regimen (second-/third-line treatment).
• Tarceva is not meant to be used at the same time as certain types of chemotherapy for advanced NSCLC.
• Safety and efficacy of Tarceva have not been evaluated as first-line treatment in patients with metastatic NSCLC whose cancer have EGFR mutations other than exon 19 deletions or exon 21 (L858R).

Supporting Information