The US Food and Drug Administration (FDA) has approved alectinib (Alecensa, Genentech) in the adjuvant setting following tumor resection in patients with anaplastic lymphoma kinase (ALK)–positive non–small cell lung cancer (NSCLC), as detected by an FDA-approved test.

“Alecensa is now the first and only ALK inhibitor approved for people with ALK-positive early-stage NSCLC who have undergone surgery to remove their tumor,” Genentech wrote in a press release.

The kinase inhibitor was previously approved as first- and second-line treatment for ALK-positive metastatic NSCLC.

Approval for the adjuvant indication was based on the open-label ALINA trial that randomized 257 patients equally to either alectinib 600 mg orally twice daily or platinum-based chemotherapy following complete tumor resection.

Patients had resectable stage IB (tumor ≥ 4 cm) to IIIA tumors with ALK rearrangements identified by a locally performed FDA-approved ALK test or by a centrally performed Ventana ALK CDx assay.

In the overall study population, median disease-free survival (DFS) was not reached in the alectinib arm and was 41.3 months in the chemotherapy arm (hazard ratio [HR], 0.24; P < .0001). In patients with stages II-IIIA NSCLC, median DFS was not reached in the alectinib group and was 44.4 months in the chemotherapy arm (HR, 0.24; P < .0001).

The overall survival data were not yet mature.

The most common adverse reactions with alectinib, occurring in 20% or more patients, were hepatotoxicity, constipation, myalgia, COVID-19, fatigue, rash, and cough.

The recommended alectinib dose is 600 mg orally twice daily with food for 2 years or until disease recurrence or unacceptable toxicity.

M. Alexander Otto is a physician assistant with a master’s degree in medical science and a journalism degree from Newhouse. He is an award-winning medical journalist who worked for several major news outlets before joining Medscape Medical News. Alex is also an MIT Knight Science Journalism fellow. Email: [email protected]