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Tarceva^® (erlotinib) tablets in Non-Small Cell Lung Cancer

Tarceva^® (erlotinib) tablets is the first medicine approved by the U.S. Food and Drug Aministration (FDA) for the initial treatment for people with non-small cell lung cancer (NSCLC), whose cancer has spread to other parts of the body, that has certain types of Epidermal Growth Factor Receptor (EGFR) mutations as detected by an FDA-approved test (First-line treatment).

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).

FDA Approval History for Tarceva in NSCLC

Approved for the initial treatment for people with NSCLC, whose cancer has spread to other parts of the body, that has certain types of EGFR mutations as detected by an FDA-approved test

Approved for maintenance treatment of people whose locally advanced or metastatic NSCLC has not progressed after four cycles of platinum-based chemotherapy Only oral maintenance therapy approved for people with locally advanced or metastatic advanced NSCLC

Approved for the initial (first-line) treatment of people with metastatic NSCLC whose tumors have certain types of EGFR mutations, as detected by an FDA-approved test Cobas® EGFR Mutation Test, developed by Roche, approved to confirm the status of people whose NSCLC tumors test positive for EGFR mutations First medicine specifically approved for the initial treatment of certain types of EGFR mutation­positive metastatic lung cancer

• For initial treatment with NSCLC whose cancer has not spread to other parts of the body, it is not known if Tarceva is safe and effective in other EGFR mutations.
• Safety and efficacy of Tarceva have not been evaluated as first-line treatment in patients with metastatic NSCLC whose tumors have EGFR mutations other than exon 19 deletions or exon 21 (L858R) substitution.

The EGFR Pathway and Tarceva (Proposed Mechanism of Action)

1. Epidermal growth factor receptors (EGFR) are expressed on the cell surface of both normal and cancer cells.
2. Tarceva attaches to EGFR, which are responsible for bringing signals into the cell that tell it to grow and divide.^1,2 These signals occur when certain proteins attach to EGFR.²
3. Tarceva works inside the cell by stopping EGFR signaling, even when mutations that keep EGFR locked in an active state are not present.¹
4. By blocking EGFR activity, Tarceva may help slow or stop the growth of tumors.¹

The way Tarceva works to treat cancer is not fully known.¹

Tarceva Efficacy Profile in NSCLC

First-Line Treatment: EURTAC Study

The approval of Tarceva for initial (first-line) treatment of patients with metastatic NSCLC whose tumors have certain epidermal growth factor receptor activating mutations, as determined by an FDA-approved test, was based upon the results of the EURTAC study, a Phase lll randomized, prospective, placebo-controlled study that evaluated the first-line use of Tarceva versus platinum-based chemotherapy in 174 people with EGFR-activating mutation-positive advanced NSCLC.

Second-Line/Third-Line Treatment: BR.21 Study

The approval of Tarceva for second- and third-line treatment of advanced NSCLC was based upon results of the BR.21 study, a Phase Ill randomized, double-blind, placebo-controlled trial that evaluated Tarceva compared to placebo in 731 people with locally advanced or metastatic NSCLC who had progressed after failure of at least one chemotherapy regimen.

First-Line Maintenance Treatment: SATURN Study

The approval of Tarceva for first-line maintenance treatment of advanced NSCLC was based upon the results of the SATURN study, a Phase Ill randomized, double-blind, placebo-controlled study that evaluated Tarceva compared to placebo in 889 people with locally advanced or metastatic NSCLC whose disease did not progress during first-line platinum-based chemotherapy.

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.

• References

  ¹ Genentech. Tarceva Full Prescribing Information. 2013.

  ² Prenzel N, Fischer OM, Streit S, Hart S and Ullrich A. The Epidermal Growth Factor Receptor as a Central Element for Cellular Signal Transduction and Diversification. Endocr Relat Cancer. 2008;2001:11-31.