Effectiveness of crizotinib in patients with -positive non-small-cell lung cancer: real-world evidence in Japan.

Crizotinib, approved in Japan (2017) for -positive NSCLC, has limited real-world data. Crizotinib monotherapy real-world effectiveness and treatment status were analyzed from claims data (June 2017-March 2021; Japanese Medical Data Vision; 58 patients tested for -NSCLC). Median duration of treatment ([DoT]; primary end point), any line: 12.

A Retrospective, Multicenter, Observational Study to Evaluate Clinical Outcomes of Lorlatinib After Alectinib in Patients With -Positive NSCLC in Japan.

Introduction: Lorlatinib is an ALK tyrosine kinase inhibitor approved in Japan for the treatment of advanced + NSCLC. There has been little evidence about lorlatinib efficacy after first-line (1L) alectinib in clinical practice in Japan.

Methods: We retrospectively analyzed patients with advanced + NSCLC previously treated with 1L alectinib at multiple sites in Japan.

Real-world study of next-generation sequencing diagnostic biomarker testing for patients with lung cancer in Japan.

Our previous real-world studies raised concerns that sequential biomarker testing may lead to increased time to treatment when compared with simultaneous single biomarker testing. The Oncomine Dx target test (ODxTT), a next-generation sequencing-based multiplex biomarker panel test approved in Japan in 2019, is expected to improve time to treatment due to changes in testing methods. This retrospective observational study examined data claims for reimbursement submitted for patients with lung cancer in Japan between June 1, 2019, and March 31, 2020.

Ceritinib in Japanese patients with anaplastic lymphoma kinase (ALK)+ non-small cell lung cancer: interim analysis results of a post-marketing surveillance study.

Ceritinib is a selective anaplastic lymphoma kinase (ALK) inhibitor approved for the treatment of patients with unresectable advanced and/or recurrent ALK fusion gene-positive non-small cell lung cancer (NSCLC). As per the approval condition in Japan, this post-marketing surveillance (PMS) study evaluated the clinical safety (including adverse events [AEs], adverse drug reactions [ADRs] and priority investigation items) and efficacy (including ORR and PFS) of ceritinib in Japanese patients. Interim analysis was conducted ~ 2 years after the start of this non-interventional, multicentre, uncontrolled, open-label, special drug-use investigation and results are reported from March 28, 2016 to April 28, 2018.