Roche’s Alecensa (alectinib) has been approved by the European Commission (EC) as the first and only targeted adjuvant treatment for patients with anaplastic lymphoma kinase (ALK)-positive early-stage lung cancer.
The regulator’s decision on the ALK inhibitor, which has been specifically authorised for use as a monotherapy in adults with non-small cell lung cancer (NSCLC) at high risk of recurrence, was based on positive results from the late-stage ALINA study.
Alecensa was shown to reduce the risk of disease recurrence by an “unprecedented” 76% compared with platinum-based chemotherapy in patients with completely resected 1b to 3a ALK-positive NSCLC, Roche said.
An improvement in central nervous system disease-free survival was also observed in those receiving Alecensa, according to an exploratory analysis, and the safety and tolerability of the drug were generally consistent with previous trials in the metastatic setting.
Lung cancer is one of the leading causes of cancer death globally and NSCLC represents up to 85% of all lung cancer diagnoses.
Approximately half of all patients with early-stage lung cancer still experience a cancer recurrence following surgery, despite adjuvant chemotherapy.
Levi Garraway, Roche’s chief medical officer and head of global product development, described the EC’s decision on Alecensa as a “landmark approval for people who have historically faced a high risk of their cancer returning after surgery”.
“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,” he said.
Alecensa, created at Chugai, a member of the Roche Group, is already approved in over 100 countries as a first- and second-line treatment for ALK-positive, metastatic NSCLC.
The latest approval for the drug comes less than two months after it was 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.
The company also recently received approval from the US regulator for its human papillomavirus self-collection solution, which it hopes will address the current barriers to cervical cancer screening by offering individuals an alternative to clinician collection procedures.