BeyondSpring: FDA Rejects Plinabulin in Chemotherapy-Induced Neutropenia
By Colin Kellaher
BeyondSpring Inc. on Wednesday said the U.S. Food and Drug
Administration has rejected its application seeking approval of
plinabulin in combination with granulocyte colony-stimulating
factor for the prevention of chemotherapy-induced neutropenia.
The New York biopharmaceutical company said it received an FDA
complete response letter, indicating that the agency won't approve
the application in its current form.
BeyondSpring said the FDA found that the results of the
company's single registrational Phase 3 trial weren't sufficiently
robust to demonstrate benefit, and that a second well controlled
study would be needed to satisfy the substantial evidence
requirement to support the proposed indication.
BeyondSpring said it plans to request a meeting with the FDA,
adding that it expects to work closely with the agency to consider
the possible future clinical pathway for the drug in
chemotherapy-induced neutropenia, which may include a second
Trading in shares of BeyondSpring was halted premarket on
Write to Colin Kellaher at email@example.com
(END) Dow Jones Newswires
December 01, 2021 08:32 ET (13:32 GMT)
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