TARCEVA (erlotinib) - Use in Maintenance Treatment for Patients

Starting date:

January 21, 2016

Posting date:

January 21, 2016

Type of communication:

Dear Healthcare Professional Letter

Subcategory:

Drugs

Source of recall:

Health Canada

Issue:

Important Safety Information

Audience:

Healthcare Professionals, Hospitals, General Public

Identification number:

RA-56720

• 
  Issue
• 
  Who is affected
• 
  Report health or safety concerns

Audience

Healthcare Professionals (medical oncologists, pulmonologists/respirologists, radiation oncologists, oncology nurses, pharmacy associations, medical associations, chiefs of medicine in hospitals, hospital pharmacy chiefs, study investigators) and patient groups.

Key messages

• The benefit-risk of TARCEVA as maintenance treatment in patients with advanced non-small cell lung cancer (NSCLC) whose tumours do not have an epidermal growth factor receptor (EGFR) activating mutation is not considered favourable.
• TARCEVA is not effective for maintenance treatment in patients with locally advanced or metastatic NSCLC whose tumours do not have an EGFR activating mutation.
• The Canadian prescribing and consumer information for TARCEVA will be updated to reflect the new data.

Issue

A recent study, IUNO (B025460), demonstrated that the benefit-risk of using TARCEVA for maintenance treatment after 4 cycles of standard platinum-based first line chemotherapy in patients with locally advanced or metastatic NSCLC whose tumours do not have an EGFR activating mutation is negative.

Products affected

TARCEVA^® (erlotinib) tablets

Background information

TARCEVA (erlotinib) is a Human Epidermal Growth Factor Receptor Type 1/Epidermal Growth Factor Receptor (HER1/EGFR) tyrosine kinase inhibitor. It is currently indicated in patients with locally advanced or metastatic NSCLC:

• After failure of at least one prior chemotherapy regimen, and whose EGFR expression status by immunohistochemistry (IHC) is positive or unknown;
• As maintenance treatment in patients with stable disease after 4 cycles of standard platinum-based first-line chemotherapy; no survival benefit is demonstrated in patients with EGFR-IHC negative or indeterminate tumours;
• As first-line treatment in patients with EGFR activating mutations.

The IUNO study (BO25460; NCT01328951) is a randomized, double-blind, placebo-controlled, phase 3 study of maintenance TARCEVA versus TARCEVA at the time of disease progression in patients with advanced NSCLC whose tumours did not harbor an EGFR-activating mutation (exon 19 deletion or exon 21 L858R mutation) and who have not progressed following 4 cycles of platinum-based chemotherapy.

Patients were randomized to receive maintenance TARCEVA or maintenance placebo followed by chemotherapy/best supportive care or TARCEVA upon disease progression, respectively. Primary endpoint was overall survival.

Overall survival was not superior in patients randomized to receive maintenance TARCEVA followed by chemotherapy upon progression compared to patients randomized to receive maintenance placebo followed by TARCEVA upon progression (HR=1.02, 95% CI, 0.85 to 1.22, p=0.82). In the maintenance phase, patients who received TARCEVA did not have superior progression-free survival compared with patients who received placebo (HR=0.94, 95% CI, 0.80 to 1.11, p=0.48).

Based on the results observed in the IUNO study, the benefit-risk of TARCEVA is negative for maintenance treatment in patients whose tumours do not have an EGFR activating mutation. The study was not designed to demonstrate efficacy in patients whose tumours do have an EGFR activating mutation. Health Canada will be reviewing the maintenance indication.

Who is affected

Information for consumers

TARCEVA is prescribed for non-small cell lung cancer at an advanced stage.

TARCEVA belongs to a group of medicines called epidermal growth factor receptor tyrosine kinase inhibitors, which are used to treat cancer. TARCEVA prevents the activity of a protein called epidermal growth factor receptor (EGFR). This protein is known to be involved in the growth and spread of cancer cells.

Based on the results of a recent study, the use of TARCEVA is not supported for maintenance treatment in patients with a type of advanced lung cancer known as non-small cell whose tumours do not have a specific EGFR mutation.

Patients and caregivers should contact their healthcare professional for more information about continuing treatment with TARCEVA. Do not discontinue the drug on your own. Contact your doctor to discuss what this new information means for you.

Information for health care professionals

The benefit-risk of TARCEVA is negative in the maintenance setting in patients with locally advanced or metastatic NSCLC whose tumours do not have an EGFR activating mutation.  The role of Tarceva as maintenance therapy in patients whose tumours harbor an EGFR activating mutation (exon 19 deletion or exon 21 L858R mutation) with locally advanced or metastatic NSCLC will be assessed by Health Canada.

The Canadian prescribing information will be updated to reflect the change to the indication.

Action taken by Health Canada

Health Canada, in collaboration with Hoffmann-La Roche Limited, will update the Canadian prescribing and consumer information for TARCEVA to reflect this updated data from the IUNO study.

Report health or safety concerns

Managing marketed health product-related side effects depends on healthcare professionals and consumers reporting them. Any adverse event or other serious or unexpected side effects in patients receiving TARCEVA should be reported to Hoffmann-La Roche Limited or Health Canada.

Hoffmann-La Roche Limited

Drug Safety Department

7070 Mississauga Road

Mississauga, Ontario, L5N 5M8

Toll free: 1-888-762-4388

Fax: 905-542-5864

E-mail: mississauga.drug_safety@roche.com

To correct your mailing address or fax number, contact Hoffmann-La Roche Limited.

You can report any suspected adverse reactions associated with the use of health products to Health Canada by:

• Calling toll-free at 1-866-234-2345; or
• Visiting MedEffect Canada's Web page on Adverse Reaction Reporting for information on how to report online, by mail or by fax.

For other health product inquiries related to this communication, contact Health Canada at:

Marketed Health Products Directorate

E-mail: mhpd_dpsc@hc-sc.gc.ca

Telephone: 613-954-6522

Fax: 613-952-7738

Original signed by

Hany Moselhi

Vice President, Medical Affairs

Hoffmann-La Roche Limited

If you require this information in an accessible format, please contact Roche at 1-800-561-1759.