...Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) today announced that it has obtained approval from the Japanese Ministry of Health, Labour and Welfare to manufacture and market “ALUNBRIG® Tablets 30 mg, 90 mg" (brigatinib, development code: AP26113) as a first and second-line therapy for the treatment of patients with unresectable, advanced or recurrent ALK fusion gene-positive non-small cell lung cancer (ALK+ NSCLC).

...Typing of ALK fusion variants in tumor samples`Typing of ALK fusion variants in blood samples`Assessment of TP53 mutation status in tumor samples`Assessment of TP53 mutation status in blood samples`Detection of "acquired resistance" mutations via standardized next-generation sequencing (NGS)-based multiplex analysis in tumor samples`Detection of "acquired resistance" mutations via standardized next-generation sequencing (NGS)-based multiplex analysis in blood samples`Typing of ALK fusion variants in cerebrospinal fluid in "brain-only" progression.`...

...Participants with unresectable advanced/recurrent ALK fusion gene-positive non-small cell lung cancer....

...For participants without documented progression or subsequent therapy, all available response designations will contribute to the BOR determination.o intracranial DOR (iDOR), defined as the time from documentation of CR or PR according to RECIST v1.1 (whichever is first recorded) until the first date that the intracranial PD is objectively documented or until death (whichever occurs first).o time to intracranial progression (TTiP), defined as the time from start of 1st-line treatment until the occurrence of a new CNS lesion or progression of pre-existing CNS lesions (adjusted for the two competing events “death” and “extracranial progression inducing a change in ALK inhibitor treatment")· QoL assessed with SF-12 and EORTC-QLQ-BN20 (EORTC-QLQ-BN20 in case of brain metastases, only)· Safety and tolerability including type, incidence and severity of AEs, SAEsExploratory Endpoints: · Capturing ALK fusion variants, TP53 mutation status and „acquired resistance“ mutations via standardized NGS-based multiplex analysis· Efficacy of treatment according to ALK fusion variant and TP53 status· Molecular resistance patterns after 1st-line failure· Impact of 2nd-line treatment after failure of 1st line as defined· Clinical utility of cerebrospinal fluid ctDNA analysis in “brain-only” progression...