Roche Products (Ireland) has announced that Alecensa (alectinib) monotherapy, as adjuvant treatment following tumour resection for adult patients with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) at high risk of recurrence (Stage IB [≥4 cm]–IIIA ALK +NSCLC has received a licence in the European Union. Data from the Phase III ALINA trial, where Alectinib demonstrated a 76 per cent reduction in the risk of disease recurrence or death in people with resected ALK-positive NSCLC, supported the marketing authorisation application. Maitiú Ó Nualláin, Lung Oncology Patient Journey Partner at Roche Products Ireland, said; “For the first time, patients who have undergone surgical resection of ALK-positive NSCLC can be treated with an ALK inhibitor, which can reduce the risk of disease recurrence or death”.

In the ALINA study, Alectinib reduced the risk of disease recurrence or death by 76 per cent (hazard ratio [HR]=0.24, 95% CI: 0.13-0.45, p<0.0001) compared with platinum-based chemotherapy in people with completely resected IB (tumour ≥ 4 cm) to IIIA (UICC/AJCC 7th edition) ALK-positive NSCLC.

The recommended dose of Alectinib is 600 mg (four 150mg capsules) taken twice daily with food (total daily dose of 1200 mg). Patients with underlying severe hepatic impairment (Child-Pugh C) should receive a starting dose of 450mg taken twice daily with food (total daily dose of 900mg)