Roche’s Alecensa (alectinib) has been recommended by the National Institute of Health and Care Excellence (NICE) as the first targeted treatment to reduce the risk of anaplastic lymphoma kinase (ALK)-positive lung cancer returning after complete tumour removal.
The drug has been specifically recommended by the health technology assessment agency as an adjuvant treatment for adults with stage 1B to 3A ALK-positive non-small cell lung cancer (NSCLC).
Lung cancer is the third most common cancer in the UK and NSCLC accounts for approximately 90% of all cases. ALK-positive NSCLC is an aggressive form of the disease and is common in younger patients with little or no smoking history.
Just under 100 people in England will be eligible to receive Alecensa, which is taken orally twice daily and designed to specifically target the ALK gene.
NICE’s decision was supported by positive results from the late-stage ALINA study, in which Alecensa reduced the risk of disease recurrence or death by 76% compared with standard-of-care platinum-based chemotherapy in patients with completely resected 1b to 3a ALK-positive NSCLC.
Alecensa also showed a meaningful delay in central nervous system recurrence or death compared with chemotherapy and appeared to be generally well-tolerated with a manageable toxicity profile.
Ouali Omani, UK lead for lung, Roche Products, said: “ALK-positive NSCLC is an aggressive form of lung cancer. Despite currently available treatments, the risk of disease recurrence in those with ALK-positive early-stage NSCLC remains high, so there is still a significant unmet need for treatments for these patients.”
The recommendation comes four months after Alecensa was granted approval by the European Commission as an adjuvant treatment for ALK-positive NSCLC patients.
Levi Garraway, Roche’s chief medical officer and head of global product development, described the EU regulator’s decision as a “landmark approval for people who have historically faced a high risk of their cancer returning after surgery”.
The drug was also recently approved by the US Food and Drug Administration (FDA) as an adjuvant treatment following tumour resection for patients with ALK-positive NSCLC, as detected by an FDA-approved test.