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

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

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

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

Tuba Khan

Tuba Khan is Senior Editor at PharmaShots. She is curious, creative, and passionate about recent updates and innovation in the Life sciences industry. She covers Biopharma, MedTech, and Digital health segments. Tuba also has an experience of digital and social media marketing and runs the campaigns independently. She can be contacted on tuba@pharmashots.com

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