ADR that result in revision of patient information
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| Canada: TARCEVA (erlotinib) - Use in maintenance treatment for patients |
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Health Canada announces that 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.
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. Details of the study can be found at the Health Canada website.
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.
Health care professionals are advised that 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.
Please refer to the following website in Health Canada for details:
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/../56720a-eng.php
In Hong Kong, there are six registered pharmaceutical products containing erlotinib, namely Tarceva Tab 25mg (HK-54114), Tarceva Tab 100mg (HK-54113), Tarceva Tab 150mg (HK-54112), Tarceva Tab 25mg (Italy) (HK-57441), Tarceva Tab 100mg (Italy) (HK-57440) and Tarceva Tab 150mg (Italy) (HK-57439). All products are prescription only medicines and are registered by Roche Hong Kong Limited (Roche HK). On 22 January 2016, Roche HK notified the Department of Health (DH) that the company would issue a "Dear Healthcare Professional Letter" to relevant oncologists, pulmonologists and pharmacists; and the information had already been posted on the Drug Office website. So far, DH has received five cases of adverse drug reactions related to erlotinib, and two of them were related to disease progression. In view of the above announcement, the matter will be discussed by the Registration Committee of the Pharmacy and Poisons Board. DH will continue to remain vigilant on the safety of medicines containing erlotinib.
Ends/ Friday, January 22, 2016
Issued at HKT 14:00 |
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