The Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) to BeyondSpring Pharmaceuticals regarding the New Drug Application (NDA) for plinabulin in combination with granulocyte colony-stimulating factor (G-CSF) for the prevention of chemotherapy-induced neutropenia (CIN).

Plinabulin is an investigational first-in-class selective immunomodulating microtubule-binding agent. The NDA submission included data from the phase 3 PROTECTIVE-2 study (ClinicalTrials.gov Identifier: NCT03294577), which showed superior CIN prevention benefit with plinabulin in combination with pegfilgrastim vs pegfilgrastim alone. 

In the CRL, the FDA stated that the application could not be approved in its present form because “results of the single registration trial were not sufficiently robust to demonstrate benefit.” The FDA is requiring a second well controlled trial to “satisfy the substantial evidence requirement to support the CIN indication.”

“BeyondSpring strongly believes that plinabulin in combination with G-CSF has significant potential to raise the standard of care in CIN, a devastating side effect of chemotherapy,” said Dr Lan Huang, BeyondSpring’s co-founder, CEO and chairwoman. “The Company plans to request a meeting with the FDA and remains committed to its goal of bringing plinabulin to cancer patients in need globally.”

References

  1. BeyondSpring Pharmaceuticals receives Complete Response Letter from the FDA for plinabulin New Drug Application for prevention of chemotherapy-induced neutropenia (CIN). News release. BeyondSpring Pharmaceuticals. Accessed December 2, 2021. https://beyondspringpharma.com/beyondspring-pharmaceuticals-receives-complete-response-letter-from-the-fda-for-plinabulin-new-drug-application-for-prevention-of-chemotherapy-induced-neutropenia-cin/
  2. BeyondSpring announces US FDA acceptance and Priority Review of New Drug Application for plinabulin and G-CSF combination for the prevention of chemotherapy-induced neutropenia (CIN). News release. June 1, 2021. https://www.globenewswire.com/news-release/2021/06/01/2239327/0/en/BeyondSpring-Announces-U-S-FDA-Acceptance-and-Priority-Review-of-New-Drug-Application-for-Plinabulin-and-G-CSF-Combination-for-the-Prevention-of-Chemotherapy-Induced-Neutropenia-CI.html.