BeyondSpring Submits NDA to the US FDA and China NMPA for Plinabulin to Prevent CT-Induced Neutropenia

April 2, 2021 Auto Bot BeyondSpring, FDA, NDA, NMPA, Plinabulin, Prevent, regulatory, reports, Submission 0

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

Click here to­ read full press release/ article | Ref: Globe Newswire | Image: Beyond Spring Pharma

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