LORBRENA Fills an Important Unmet Need

Potential treatment scenarios in ALK-positive metastatic NSCLC

LORBRENA is indicated for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) whose disease has progressed on

  • crizotinib and at least one other ALK inhibitor for metastatic disease; or
  • alectinib as the first ALK inhibitor therapy for metastatic disease; or
  • ceritinib as the first ALK inhibitor therapy for metastatic disease.

This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

The LORBRENA Trial
LORBRENA was studied in a subgroup patient population that received a variety of prior ALK inhibitor therapies, including alectinib or ceritinib in first line
Phase 1/2, non-randomized, dose-ranging, activity-estimating, single-arm, multi-cohort, multicenter trial2
trial_design_desktop
unmet_mob

According to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and as assessed by Independent Central Review (ICR) committee.

Chemotherapy administered in the metastatic setting.