TAKEDA PHARMS USA — Velcade FDA Review (NDA/BLA 021602, 2017)
Takeda Pharmaceutical Company Limited · 2017 · FDA Review (Drugs@FDA) · company profile →
Report summary
The FDA approved a supplemental New Drug Application for Velcade (bortezomib) to include a subcutaneous (SC) route of administration as an alternative to intravenous (IV). This approval, granted on January 23, 2012, was based on the Phase 3 MMY-3021 study, which demonstrated non-inferior efficacy of SC Velcade compared to IV Velcade in multiple myeloma patients, alongside a superior safety profile, particularly regarding peripheral neuropathy. A Phase 1 PK/PD study (CAN-1004) supported comparable drug exposure. The review also addressed usability concerns and potential medication errors, recommending label revisions. Nonclinical and statistical reviews further supported the approval, while postmarketing data indicated a possible association with QT prolongation.
Key findings — cited to the page
| vomiting grade ≥ 3 (SC arm) | 2 % | · p.130 |
| vomiting all grades (IV arm) | 16.2 % | · p.130 |
| diarrhea grade ≥ 3 (SC arm) | 2 % | · p.130 |
| vomiting all grades (SC arm) | 11.5 % | · p.130 |
| diarrhea grade ≥ 3 (IV arm) | 5.4 % | · p.130 |
| neutropenia all grades (IV arm) | 27 % | · p.130 |
| neutropenia (Grade 3-4) in IV group | 17.6 % | · p.126 |
| diarrhea all grades (SC arm) | 24.3 % | · p.130 |
| neutropenia (Grade 3-4) in SC group | 17.6 % | · p.126 |
| diarrhea all grades (IV arm) | 36.5 % | · p.130 |
| neutropenia grade ≥ 3 (IV arm) | 17.6 % | · p.130 |
| vomiting grade ≥ 3 (IV arm) | 1.4 % | · p.130 |
Source: Takeda Pharmaceutical Company Limited ↗ · License: US Government public domain. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Oncology library →