Velcade(bortezomib)
Oncology· 1376 cited findings· 3 source documents
Company: Johnson & Johnson →
What the regulatory reviews say
Velcade (bortezomib) is indicated for the treatment of patients with multiple myeloma and for patients with mantle cell lymphoma who have received at least 1 prior therapy. The drug received initial approval in 2003, with a label modification on March 25, 2005, and a subsequent approval on January 23, 2012, under sNDA Supplement 027 (NDA/BLA 021602).
Efficacy was evaluated in a randomized phase 3 study involving 222 subjects. The overall response rate (complete response + partial response) after 4 cycles was 43% for subcutaneous (SC) administration and 42% for intravenous (IV) administration. The non-inferiority of SC administration was demonstrated with a p-value of 0.001. The MR rate (ITT population) was 14% for both SC and IV groups. For safety, Grade 3-4 neutropenia was 17.6% in both SC and IV groups. Diarrhea (all grades) was 24.3% for SC and 36.5% for IV, with Grade ≥ 3 diarrhea at 2% for SC and 5.4% for IV.
Key figures — cited to the source page
| Overall Response Rate (CR+PR) after 4 cycles (SC) | 43 | TAKEDA PHARMS USA — Velcade FDA Review, p.70 |
| Overall Response Rate (CR+PR) after 4 cycles (IV) | 42 | TAKEDA PHARMS USA — Velcade FDA Review, p.70 |
| p-value for non-inferiority | 0.001 | TAKEDA PHARMS USA — Velcade FDA Review, p.70 |
| Neutropenia (Grade 3-4) in SC group | 17.6 | TAKEDA PHARMS USA — Velcade FDA Review, p.126 |
| Neutropenia (Grade 3-4) in IV group | 17.6 | TAKEDA PHARMS USA — Velcade FDA Review, p.126 |
| Diarrhea all grades (IV arm) | 36.5 | TAKEDA PHARMS USA — Velcade FDA Review, p.130 |
| Approval Date | 01/23/2012 | TAKEDA PHARMS USA — Velcade FDA Review, p.1 |
| Initial Approval Date | 2003 | TAKEDA PHARMS USA — Velcade FDA Review, p.71 |
Source documents
Explore the full evidence
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Figures are as stated in the cited regulatory review documents (different drugs are studied in different trials — values are not head-to-head comparisons). Educational reference only — not medical or investment advice.