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Tarceva® (erlotinib): First-line maintenance indication now restricted to treatment of patients whose tumours harbour an EGFR-activating mutation

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Date: 1 July 2016

 

Description:

Tarceva® (erlotinib) is no longer indicated for the first-line maintenance treatment in patients without an epidermal growth factor receptor (EGFR)-activating mutation based on data from the IUNO study. The results of the IUNO study led to the conclusion that the benefit-risk of Tarceva® is no longer considered favourable 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. Please refer to the DHPC issued by Roche (Malaysia) Sdn. Bhd. for further information.

 

National Pharmaceutical Regulatory Agency (NPRA)

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