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Briefing note: erlotinib (Tarceva)

SMC accepted erlotinib for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) activating mutations.

NSCLC is a type of lung cancer. About 80 out of every 100 lung cancers are diagnosed as NSCLC, and it is usually caused by smoking.

Epidermal growth factor receptors (EGFRs) are located on the surface of many types of cancer cells and they allow epidermal growth factor (a protein present in the body) to attach to them causing chemical processes to occur inside the cell that make it grow and divide more quickly. Erlotinib is an EGFR inhibitor that prevents the receptor from being activated and stops the cancer cells from growing so quickly.
It is taken as a tablet once daily, at least 1 hour before or 2 hours after food.

  • SMC has previously accepted erlotinib for restricted use for second-line treatment in locally advanced or metastatic NSCLC. This submission relates to a licence extension allowing erlotinib to be used as a first-line treatment in patients whose cancer cells have EGFR receptors (around 11% of patients with metastatic NSCLC).
     
  • A study showed that erlotinib increased progression-free survival by 4.2 months compared with another chemotherapy regime.
     
  • There were no new safety issues associated with erlotinib. Skin rash and diarrhoea were more commonly reported with erlotinib compared with placebo (a dummy medicine containing no active treatment).
     
  • This SMC advice takes account of the benefits of a patient access scheme (PAS). A PAS is a scheme proposed by a manufacturer in order to improve the cost effectiveness of a medicine and thus enable patients to receive access to new medicines that may otherwise not have been judged to be a cost-effective use of NHS resources. The proposed PAS gives a discount on the price of the medicine.
     
  • SMC accepted erlotinib for first-line treatment of patients with locally advanced or metastatic
    NSCLC with EGFR activating mutations because the balance of costs and benefits when the
    PAS was taken into account meant that it was considered to offer value for money.