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# Marqibo Accelerated Approval Withdrawn
- URL: https://www.fdaweb.com/marqibo-accelerated-approval-withdrawn/
- Published: 2022-05-02T12:00:00.000Z
- Updated: 2026-09-14T17:42:56.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5151716

*Federal Register* notice: FDA is withdrawing the accelerated approval of Acrotech Biopharma’s NDA for Marqibo (vincristine sulfate liposome injection), indicated for treating certain adult patients with Philadelphia chromosome-negative acute lymphoblastic leukemia. The company requested the withdrawal due to agency concerns that a postmarketing trial required to verify clinical benefit had not been completed, and patient recruitment to fulfill the requirement appeared to be significantly challenging due to the treatment options that are currently available. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2022-05-02/pdf/2022-09235.pdf?ref=fdaweb.com).