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Article History

Accepted: 30 January 2025

First Online: 26 February 2025

Declarations

:

: This study was supported by Takeda Argentina S.A.

: Claudio Martin received consulting fees from Pfizer, Astra Zeneca, Takeda, Boehringer Ingelheim and Roche. Gabriela Ileana Malcervelli received travel support and consulting fees from Takeda. Lucas Gastón Martinengo has no conflict of interest that are directly relevant to the content of this article. Patricio Servienti received travel support from Raffo, GSK, Takeda, Merck, BMS and Pfizer; lecture fees from GSK and Raffo; and consulting fees from Pfizer. Patricio Levit received lectures fees from Roche, Takeda and AstraZeneca, and consulting fees from Tuteur. Elisa Malaver, Laura Brion, Vanesa Patronella and Andrea Zumarrága are employees of Takeda Argentina S.A. Jose Zarba received travel support from MSD, BMS and Takeda; lecture fees from Novartis, BMS and MSD; and consulting fees from MSD, Takeda and AstraZeneca.

: The study protocol (Brigatinib-5008) was approved by an independent ethics committee (Fundación de Estudios Farmacológicos y Medicamentos, FEFyM) on 21 October, 2020. All patients were required to provide mandatory written informed consent. Good pharmacoepidemiology practice guidelines, local applicable regulations and the Declaration of Helsinki were followed. Furthermore, this study conformed to all regulations concerning the use of personal data. The study was incorporated in the clinical study registry of the city of Buenos Aires, Argentina (PRIISA-BA #3201) and in ClinicalTrials.gov (NCT04887519).

: To receive brigatinib during the post-marketing surveillance study period, eligible patients were required to provide a written inform consent in the presence of the treating physician. The patients were informed about the medication and the scope of the study before providing their consent.

: Not applicable.

: The datasets, including the redacted study protocol, redacted statistical analysis plan and individual participant data supporting the results reported in this article, will be made available within 3 months from initial request to researchers who provide a methodologically sound proposal. The data will be provided after its de-identification, in compliance with applicable privacy laws, data protection and requirements for consent and anonymization.

: Not applicable.

: CM, GIM, LGM, PS, PL and JZ participated in patient recruitment and data collection. EM, LB, VP, AZ and JZ participated in study design. All authors participated in the analysis and interpretation of data and contributed to writing and critical revision of all drafts.