Direct healthcare professional communication on the restriction of indication for treatment with Tarceva (erlotinib)
Roche d.o.o., in agreement with the Agency for Medicinal Products and Medical Devices of Croatia (HALMED) and the European Medicines Agency (EMA), has informed healthcare professionals of the restriction of indication for treatment with Tarceva (erlotinib). The indication in maintenance treatment after first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) is now limited to treatment of patients with epidermal growth factor receptor (EGFR) activating mutations.
- Based on the results of the IUNO study, Tarceva is no longer indicated for maintenance treatment after first-line treatment in patients without an EGFR-activating mutation. This 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 tumors do not harbor an EGFR-activating mutation is no longer considered favorable.
- The indication is changed to the following wording: "Tarceva is also indicated for switch maintenance treatment in patients with locally advanced or metastatic NSCLC with EGFR activating mutations and stable disease after first-line chemotherapy".
The letter provides healthcare professionals with information on the results of the IUNO study, based on which the indication of the medicinal product has been restricted, as well as with changes in the corresponding sections of the Summary of Product Characteristics for Tarceva.
Here you may view the direct healthcare professional communication.
The healthcare professionals are being reminded that they should report any adverse reaction, as well as quality defect to HALMED. Patients who have developed any adverse reaction to medicinal product may report it directly to HALMED. HALMED recommends the patients to contact their doctor or pharmacist regarding any adverse reaction they notice.