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

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.

Full Prescribing Information

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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).

Supporting Information

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).

Important Safety Information

• Serious side effects (including deaths) in patients taking Tarceva include Interstitial Lung Disease (ILD)-like events; liver and/or kidney problems; gastrointestinal (GI) perforations (the development of a hole in the stomach, small intestine, or large intestine); serious skin conditions; and bleeding events including gastrointestinal and non-gastrointestinal bleeding when taking warfarin or non-steroidal anti-inflammatory drugs (NSAIDs).
• Patients taking Tarceva plus gemcitabine were more likely to experience bleeding and clotting problems such as heart attack or stroke.
• Eye irritation and damage to the cornea have been reported in patients taking Tarceva.
• Women should avoid becoming pregnant and avoid breastfeeding while taking Tarceva.
• Patients should call their doctor right away if they have these signs or symptoms: new or worsening skin rash; serious or ongoing diarrhea, nausea, loss of appetite, or vomiting; new or worsening shortness of breath or cough; or eye irritation.
• Rash and diarrhea were the most common side effects associated with Tarceva in the non-small cell lung cancer clinical studies.
• Fatigue, rash, nausea, loss of appetite, and diarrhea were the most common side effects associated with Tarceva plus gemcitabine therapy in the advanced pancreatic cancer clinical study.

 

View full prescribing information for additional safety information.