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FDA称百时美施宝术
2024-08-08 01:53
- Bristol Myers Squibb (NYSE:BMY) has received an "untitled letter" from the U.S. FDA Office of Prescription Drug Promotion over alleged misleading claims being made on a physician website for its cancer drug Krazati (adagrasib).
- The agency said that the issue in particular has to do with a section discussing efficacy results from the KRYSTAL-1 trial, a single-arm study.
- "This presentation misleadingly suggests that Krazati improves [disease control rate] and 'depth of response' in patients with KRAS G12C-mutated locally advanced or metastatic [non-small cell lung cancer] based on a composite of [completed response, partial response, and stable disease], even though the study was not designed to demonstrate this," the letter reads.
- The FDA also faults Bristol regarding Krazati treating brain metastases, arguing it is misleading because this has not been demonstrated in a post hoc analysis.
- Krazati was approved under the FDA's accelerated approval process in 2022, meaning Bristol needs to conduct a confirmatory trial further demonstrating its efficacy.
- The agency asks Bristol to respond within 15 days regarding it concerns.
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