Basel, 10 June 2024 – Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the European Commission has approved 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 NSCLC [7th edition UICC/AJCC]). Data from the Phase III ALINA trial, where Alecensa demonstrated an unprecedented 76% reduction in the risk of disease recurrence or death in people with resected ALK-positive NSCLC, supported the marketing authorisation application.1 “For the first time, people in Europe who have undergone surgical resection of ALK-positive NSCLC can be treated with an ALK inhibitor, which can significantly reduce the risk of disease recurrence or death,” said Levi Garraway, M.
D., Ph.D.
, Roche's Chief Medical Officer and Head of Global Product Development.“This is a landmark approval for people who have historically faced a high risk of their cancer returning after surgery. We are now able to bring the transformational benefits of Alecensa to even more people with ALK-positive lung cancer.
” “When it comes to early stage ALK-positive NSCLC, surgery is not always enough as there remains a high risk of recurrence that leaves patients concerned about what's to come,” said Professor Fabrice Barlesi, thoracic oncologist, Paris Saclay University and chief executive officer of Gustave Roussy Institute.“T.