TARCEVA (erlotinib), tyrosine kinase inhibitor

Insufficient clinical benefit to justify reimbursement in the treatment of locally advanced or metastatic forms of non-small cell lung cancer after failure of at least one line of chemotherapy in patients with a tumour without EGFR-activating mutation, when the other treatment options are not deemed appropriate.

• TARCEVA has been granted a marketing authorisation for the treatment of locally advanced or metastatic forms of non-small cell lung cancer (NSCLC) after failure of at least one line of chemotherapy. In patients with tumours without EGFR-activating mutation, when other treatment options are inappropriate.

• Since the availability of anti-PD-1/PD-L1 immunotherapies, TARCEVA no longer has a role in the therapeutic strategy for this indication, particularly after the third line of treatment, after failure of immunotherapies and chemotherapy. 

• No methodologically acceptable data are available to document its efficacy or safety in the situations described by the MA.