Trial Profile
A Phase 3, Randomized Study to Evaluate Plinabulin Versus Pegfilgrastim in the Prevention of Severe Neutropenia in Breast Cancer Patients Receiving Myelosuppressive Chemotherapy With Docetaxel, Doxorubicin, and Cyclophosphamide (TAC) (Protective 2)
Status:
Active, no longer recruiting
Phase of Trial:
Phase III
Latest Information Update: 25 Apr 2023
Price :
$35
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At a glance
- Drugs Plinabulin (Primary) ; Cyclophosphamide; Docetaxel; Doxorubicin; Pegfilgrastim
- Indications Neutropenia
- Focus Registrational; Therapeutic Use
- Acronyms Protective 2
- Sponsors BeyondSpring Pharmaceuticals
- 01 Mar 2023 According to BeyondSpring Pharmaceuticals media release, the company withdrew its NDA submission for the CIN indication from China's National Medical Products Administration (NMPA) review. The Company will continue to communicate with the NMPA regarding its re-filing of the NDA for the CIN indication and plan to re-file the NDA by mid-2023.
- 07 Jun 2022 Results presented at the 58th Annual Meeting of the American Society of Clinical Oncology
- 01 Dec 2021 According to BeyondSpring Pharmaceuticals media release, the company has received a Complete Response Letter from the U.S FDA to NDA, indicating NDA application cannot be approved as results from Study 106 was not sufficiently robust to demonstrate benefit and that a second well controlled trial would be required to satisfy the substantial evidence requirement to support the CIN indication. The Company plans to request a meeting with the FDA.