BeyondSpring’s Plinabulin Receives the US FDA’s and NMPA’s Breakthrough Therapy Designations for Chemotherapy-Induced Neutropenia Indication

 BeyondSpring’s Plinabulin Receives the US FDA’s and NMPA’s Breakthrough Therapy Designations for Chemotherapy-Induced Neutropenia Indication

BeyondSpring’s Plinabulin Receives the US FDA’s and NMPA’s Breakthrough Therapy Designations for Chemotherapy-Induced Neutropenia Indication

Shots:

  • The designation is based on P-III PROTECTIVE-2 evaluating Plinabulin + Neulasta vs Neulasta alone for the treatment of CIN
  • In the protocol-specified interim analysis, combination regimen was better than Neulasta alone in achieving the 1EPs with p<0.01 and have a well-tolerated safety profile with fewer Grade 4 AEs
  • The company plans to report full results of the P-III PROTECTIVE-2 study in Q4’20 and file an NDA with the FDA by the end of 2020. The company has submitted an NDA to the NMPA on a rolling basis in Q1’20

Click here ­to­ read full press release/ article | Ref: GlobeNewswire | 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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