ALECENSA

What it is

Alecensa contains alectinib hydrochloride 150 mg, a tyrosine kinase inhibitor for oral administration.

Approved indications

— Adjuvant treatment in adult patients following tumour resection of anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) (tumours ≥4 cm or node positive). — Treatment of patients with ALK-positive, locally advanced or metastatic NSCLC.

Dosing overview

The recommended dose of Alecensa is 600 mg (four 150 mg capsules) given orally, twice daily with food (total daily dose of 1200 mg). For adjuvant treatment of resected NSCLC, patients are treated for a total of 2 years, or until disease recurrence or unmanageable toxicity. For treatment of locally advanced or metastatic NSCLC, patients are treated until disease progression or unmanageable toxicity. The dose may be reduced in steps of 150 mg twice daily based on tolerability. Alecensa treatment should be permanently discontinued if patients are unable to tolerate the 300 mg twice daily dose.

PBS listing

Alecensa 150 mg capsules are listed on the PBS with authority required restriction at an ex-manufacturer price of A$6320.43.

Regulatory history

Alecensa was first listed on the ARTG on 14 March 2017. The PBAC recommended Alecensa in July 2017 on a cost-minimisation basis against ceritinib for the treatment of ALK-positive NSCLC. In November 2017, the PBAC recommended Alecensa for the treatment of ALK-positive advanced NSCLC in adult patients who had previously been treated with crizotinib. The TGA approved Alecensa on 30 January 2018 for the treatment of patients with ALK-positive, locally advanced or metastatic NSCLC, extending its use to include first-line treatment. In May 2025, the PBAC recommended Alecensa for adjuvant treatment in adult patients following tumour resection of ALK-positive NSCLC (tumour ≥4 cm or node positive).