Expert consensus on off-label use of solvatinib

Title: Expert consensus on off-label use of solvatinib
Edition: Original
Classification: Experts consensus
Field: Administration
Countries and regions: China
Guidelines users: Oncology-related clinicians, pharmacists
Evidence classification method: Refer to the CSCO guidelines for evidence evaluation criteria: (1) 1A: Level: high, source: rigorous meta-analysis, large randomized controlled clinical studies, expert consensus: consensus (support opinion ≥80%); (2) 1B: Level: high, source: rigorous meta-analysis, large randomized controlled clinical studies, expert consensus: basically unanimous consensus, but little controversy (support opinions 60%~80%); (3) 2A: Level: slightly low, sources: meta-analyses of general quality, small randomized controlled studies, large well-designed retrospective studies, case-control studies, expert consensus: consensus (support ≥80%); (4) 2B: Level: slightly lower, sources: type II randomized controlled studies, well-designed large retrospective studies, case-control studies, expert consensus: basically unanimous consensus, but little controversy (support opinions 60%~80%); (5) 3: Level: low, sources: non-controlled single-arm clinical studies, case reports, expert opinions, expert consensus: no consensus, and highly controversial (Support opinion <60%).
Development unit: Zhejiang Anti-Cancer Association Oncology Clinical Pharmacy Professional Committee, Zhejiang Pharmaceutical Association Anti-Tumor Drug Professional Committee
Registration time: 2024-03-26
Registration number: PREPARE-2024CN466
Purpose of the guideline: Sopantinib is a new oral tyrosine kinase inhibitor independently developed in China. The indication approved by the State Drug Administration is neuroendocrine tumor, but off-label drug use is common in clinical practice. In order to make more rational use of solantinib, this consensus summarizes and evaluates the evidence-based evidence of solantinib based on drug labels, published literature evidence, guidelines and expert consensus, and provides reference for off-label use of solantinib.