Shots:

• The NDA submission is based on data from P-III PROTECTIVE-2 study evaluating Plinabulin + Neulasta vs Neulasta alone for the prevention of CIN
• The study met its 1EPs and 2EPs with an improvement in the rate of prevention of grade 4 neutropenia from 13.6% to 31.5%- the 2 EPs include DSN and ANC. The results demonstrated superior CIN prevention benefit- reduced clinical complications such as incidence- severity of febrile neutropenia and duration of hospitalization for FN patients- well- tolerated- 20% reduction of grade 4 TEAEs
• The NDA submissions will include 5 trials in 1200 patients to show consistent CIN prevention in various CT regimens and cancers

  Ref: Globe Newswire | Image: Beyond Spring Pharma