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
Ref: GlobeNewswire | Image: Beyond Spring Pharma
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Tuba was Senior Editor at PharmaShots. She was curious, creative, and passionate about recent updates and innovations in the life sciences industry. She covered Biopharma, MedTech, and Digital health segments. Tuba also had an experience in digital and social media marketing and ran the campaigns independently. She can be contacted at connect@pharmashots.com.
