Other safety alerts
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| Tarceva® (erlotinib): First line maintenance treatment not demonstrating benefit in patients whose tumours do not harbour an EGFR-activating mutation |
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Roche Hong Kong Limited (Roche HK), a licensed drug wholesaler, informed the Department of Health (DH) that Tarceva® (erlotinib) as a first line maintenance treatment did not demonstrate benefit in patients whose tumours do not harbour an EGFR-activating mutation.
The results of the IUNO study led to the conclusion that the benefit-risk of Tarceva for maintenance treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) after 4 cycles of standard platinum-based first line chemotherapy whose tumours do not harbour an EGFR-activating mutation is no longer considered favourable.
In Hong Kong, six registered pharmaceutical products are approved under the brand name of Tarceva, 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 HK. Roche HK notified the Department of Health (DH) that the company would issue a "Dear Healthcare Professional Letter" to relevant oncologists, pulmonologists and pharmacists today (22 January 2016). So far, DH has received five cases of adverse drug reactions related to erlotinib, and two of them were related to disease progression. DH will maintain close contact with Roche HK to monitor any action deemed necessary and continue to remain vigilant on the safety of medicines containing erlotinib.
Ends/ Friday, January 22, 2016
Issued at HKT 09:00
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