Phase III trial data shows that a developmental drug, plinabulin, could help keep cancer patients on needed chemotherapy treatments.
Developers at BeyondSpring will now seek FDA approval—citing that the study reached primary endpoints and significant secondary endpoints including decreased rate of grade 4 neutropenia and shorter duration of severe and profound neutropenia.
Plinabulin is sponsored by BeyondSpring.
Plinabulin is a small molecule therapy that is administered through an IV. Data show it significantly decreased incidence of chemotherapy-induced neutropenia when used with standard of care, compared to patients receiving standard of care alone.
CIN is the primary cause of reductions in dose or duration of chemotherapy, which can ultimately lead to less effective cancer treatment. About 86% of oncologists consider CIN a priority among chemotherapy-related treatment decisions because reductions in chemo lead to decreased survival for patients. Plinabulin can potentially be used at any time throughout the chemo cycle.
In addition to seeking FDA approval, BeyondSpring is also expected to seek approval in China in early 2021.