> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Complete Response Letter for Plinabulin
- URL: https://www.fdaweb.com/complete-response-letter-for-plinabulin/
- Published: 2021-12-01T12:00:00.000Z
- Updated: 2026-09-14T17:24:13.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5150671

FDA has issued a complete response letter for the BeyondSpring Pharmaceuticals NDA seeking approval of plinabulin in combination with granulocyte colony-stimulating factor to prevent chemotherapy-induced neutropenia (CIN). The company [says](https://beyondspringpharma.com/beyondspring-pharmaceuticals-receives-complete-response-letter-from-the-fda-for-plinabulin-new-drug-application-for-prevention-of-chemotherapy-induced-neutropenia-cin/?ref=fdaweb.com) the agency indicated the NDA cannot be approved at this time because the results of the single registrational Phase 3 trial were not sufficiently robust to demonstrate benefit. FDA said a second well-controlled trial would be required to satisfy the substantial evidence requirement for approval.

Company officials said they plan to seek a meeting with FDA “to consider the possible future clinical pathway for CIN, which may include a second study.”

BeyondSpring says plinabulin, its lead asset, is a selective immunomodulating microtubule-binding agent that is a potent antigen-presenting cell inducer.