ALUNBRIG® (brigatinib) Prescribing Information

ALUNBRIG is indicated as monotherapy for the treatment of adult patients with:1

  • anaplastic lymphoma kinase-positive (ALK+) advanced non-small cell lung cancer (aNSCLC) previously not treated with an ALK inhibitor
  • ALK+ aNSCLC previously treated with crizotinib

ALUNBRIG demonstrates sustained and significantly longer duration of improvement in health-related quality of life versus crizotinib2

Brain metastases, a frequent occurrence in ALK+ aNSCLC, can have profound effects on a patient's symptom burden and subsequent quality of life (QoL).3,4

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HRQoL

HRQoL data were collected via the validated EORTC QLQ‑C30 questionnaire and its lung cancer‑specific module, the QLQ‑LC13.5-7

  • The QLQ-C30 covers:5
    • five functional scales - physical, role, cognitive, emotional and social
    • three symptom scales - fatigue, pain and nausea/ vomiting
    • a global health/QoL scale
  • The QLQ-LC13 includes:6
    • measures of lung cancer-associated symptoms
    • conventional lung cancer therapy side effects

In ALTA-1L the questionnaire answers were recorded at:7

  • baseline
  • Day 1 of every cycle (4 weeks) until end of treatment
  • end of treatment
  • 30 days after last dose

HRQoL data from ALTA-1L

In the final analysis of the phase III ALTA-1L, a randomised, open-label trial comparing the efficacy and safety profile of ALUNBRIG with crizotinib in ALK+ aNSCLC previously untreated with ALK inhibitors:2

ALUNBRIG significantly delayed time to worsening in HRQoL versus crizotinib

Time to worsening in global health score/QoL score (ITT population)2


Worsening in global health score/QoL score was defined as ≥10-point worsening in score.

Kaplan-Meier curve comparing time to worsening of global health status between two treatment arms in a phase III advanced lung cancer trial

Adapted from Camidge R et al, 20212

Hazard ratios (HR) for time to worsening in global QoL and functioning scores and symptom scores2

Forest plot comparing hazard ratios for global quality of life and functioning scores between two treatment arms in a phase III advanced lung cancer trial
Forest plot comparing hazard ratios for symptom scores between two treatment arms in a phase III advanced lung cancer trial

Adapted from Camidge R et al, 20212

In the second interim analysis of ALTA-1L ALUNBRIG delivered a sustained and significantly longer duration of improvement in HRQoL vs crizotinib8

Duration of improvement in global health score/QoL score (responders)8

Kaplan-Meier curve comparing duration of improvement in global health status between two treatment arms in a phase III advanced lung cancer trial

Adapted from Camidge R et al, 20212

References and Abbreviations

EORTC, European Organisation for Research and Treatment of Cancer; QLQ‑C30, Quality of Life Questionnaire (version 3.0); QLQ‑LC13, Quality of Life Questionnaire‑lung cancer (version 3.0); HR, hazard ratio; ITT, intention-to-treat; NR, not reached; HRQoL, health-related quality of life; QoL, quality of life; TKI, tyrosine kinase inhibitor; CI, confidence interval.

1. ALUNBRIG (brigatinib) Summary of Product Characteristics. Available at: medicines.org.uk. Accessed June 2026; 2. Camidge D R, Kim H R et al. Brigatinib versus crizotinib in ALK inhibitor‑naive advanced ALK‑positive NSCLC: final results of phase 3 ALTA-1L trial. J Thorac Oncol 2021;16:2091-2108 (+ suppl); 3. Cormie P, Nowak A K et al. The potential role of exercise in neuro-oncology. Front Oncol 2015;5:85; 4. Guérin A, Sasane M et al. Brain metastases in patients with ALK+ non-small cell lung cancer: clinical symptoms, treatment patterns and economic burden. J Med Econ 2015;18:312-322; 5. Aaronson N K, Ahmedzai S et al. The European Organization for Research and Treatment of Cancer QLQ‑C30: a quality‑of‑life instrument for use in international clinical trials in oncology. J Natl Cancer Inst 1993;85:365-376; 6. Bergman B, Aaronson N K et al. The EORTC QLQ-LC13: a modular supplement to the EORTC Core Quality of Life Questionnaire (QLQ‑C30) for use in lung cancer clinical trials. EORTC Study Group on Quality of Life. Eur J Cancer 1994;30a:635-642; 7. Camidge D R, Kim H R et al. Brigatinib versus crizotinib in ALK-positive non‑small‑cell lung cancer: study protocol. N Engl J Med 2018;379:2027-2039; 8. Camidge D R, Kim H R et al. Brigatinib versus crizotinib in advanced ALK inhibitor‑naive ALK‑positive non‑small cell lung cancer: second interim analysis of the phase III ALTA-1L trial. J Clin Oncol 2020;38:3592-3603

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