The following information helps you to find FDA Alerts and Pharmacist’s Applications to Practice quickly and easily. In cooperation with the Food and Drug Administration (FDA), and as a service to our members, HOPA periodically distributes information about newly approved therapies for cancer patients from FDA’s Office of Oncology Drug Products Director, Dr. Richard Pazdur to inform oncologists and professionals in oncology-related fields in a timely manner. Links to product labels will take you to relevant clinical information on the indication, contraindications, dosing, and safety. In sending this information, HOPA does not endorse any product or therapy and does not take any position on the safety or efficacy of the product or therapy described.

Along with HOPA’s Publications Committee, members also review new drug updates and provide analysis and research on the application of these new drugs or indications. Pharmacist’s Applications to Practice, or PAP, are listed after drugs that include the additional analysis.

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October 18, 2016

On October 18, 2016, the U.S. Food and Drug Administration modified the indication for erlotinib (TARCEVA, Astellas Pharm Global Development Inc.) for treatment of non-small cell lung cancer (NSCLC) to limit use to patients whose tumors have specific epidermal growth factor receptor (EGFR) mutations.

The labeling change applies to patients with NSCLC receiving maintenance or second or greater line treatment. These indications will be limited to those patients whose tumors have EGFR exon 19 deletions or exon 21 L858R substitution mutations as detected by an FDA-approved test. The first-line indication previously was limited to patients with EGFR exon 19 deletions or exon 21 substitution mutations.

This labeling supplement is based on the results of the IUNO trial, a randomized, double-blind, placebo-controlled, trial of erlotinib administered as maintenance therapy in 643 patients with advanced NSCLC who had not experienced disease progression or unacceptable toxicity during four cycles of platinum-based first-line chemotherapy. Patients whose tumors harbored activating EGFR mutations (exon 19 deletions or exon 21 L858R mutations) were excluded from this trial. Patients were randomized 1:1 to receive erlotinib or placebo orally once daily (322 erlotinib, 321 placebo) until disease progression or unacceptable toxicity. Following progression on initial therapy, patients were eligible to enter an open-label phase. Fifty percent of patients randomized to erlotinib entered the open-label phase and received chemotherapy, while 77% of patients randomized to placebo entered the open-label phase and received erlotinib.

The trial’s primary endpoint was overall survival. Results demonstrated that survival following treatment with erlotinib was not better than placebo administered as maintenance in patients with metastatic NSCLC tumors not harboring EGFR-activating mutations. No difference in progression-free survival between the erlotinib arm and the placebo arm was observed.

FDA will not require new post-marketing requirements or request post-marketing commitments based on the results of the IUNO trial.

Full prescribing information is available at:

Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System by completing a form online at, by faxing (1-800-FDA-0178) or mailing the postage-paid address form provided online, or by telephone (1-800-FDA-1088).

Pharmacist's Application to Practice

Erlotinib for Treatment of Non–Small Cell Lung Cancer

Author: Sarah Ussery, PharmD BCOP
Senior Medical Science Liaison—Hematology
Celgene Corporation
Midlothian, TX

What is the potential role for erlotinib in the treatment of non–small cell lung cancer (NSCLC)?

  • The use of erlotinib should be limited to patients whose tumors have specific epidermal growth factor receptor (EGFR)–activating mutations.1
    • The modified indication is based on the results of the IUNO trial,2 which showed that progression-free survival (PFS) following maintenance treatment with erlotinib was no better than placebo in patients with metastatic NSCLC tumors not harboring EGFR-activating mutations.
  • Erlotinib is now approved for first-line, maintenance, and second-or-greater-line treatment of metastatic NSCLC patients harboring activating EGFR mutations, which includes exon 19 deletions and exon 21 L858R substitution mutations.1,3

What role can the pharmacist play in the management of NSCLC patients being considered for erlotinib therapy?

  • Mutational testing via an FDA-approved test must be performed prior to initiation of erlotinib therapy.3

Clinical Pearls

  • The FDA-approved companion diagnostic test for erlotinib is cobas® EGFR Mutation Test v2.1.4
  • Erlotinib should not be administered in combination with chemotherapy in NSCLC because of the lack of efficacy.3


  1. U.S. Food and Drug Administration. Erlotinib (Tarceva). Updated October 18, 2016. Accessed January 26, 2017.
  2. Cicènas S, Geater SL, Petrov P, et al. Maintenance erlotinib versus erlotinib at disease progression in patients with advanced non-small-cell lung cancer who have not progressed following platinum-based chemotherapy (IUNO study). Lung Cancer. December 2016;102:30-37.
  3. Tarceva [prescribing information]. South San Francisco, CA: Genentech USA, Inc., A Member of the Roche Group; October 2016. Accessed January 26, 2017.
  4. U.S. Food and Drug Administration. cobas EGFR Mutation Test v2. Updated June 2, 2016. Accessed February 1, 2017.