emic Anti-Lymphoma
Therapies, n (%)
Median (range)
1
2
3
≥ 4 4 (2, 10)
0 (0)
29 (22)
34 (25)
71 (53)
Number of Subjects Who Received Prior Regimen
Containing, n (%):
Anthracycline/mitoxantrone
Cyclophosphamide
Rituximab
Bortezomib 133 (99)
133 (99)
134 (100)
134 (100)
Refractory to Prior Bortezomib, n (%) 81 (60)
Refractory to Last Prior Therapy, n (%) 74 (55)
Prior Autologous Bone Marrow or Stem Cell
Transplant, n (%) 39 (29)
The efficacy endpoints in the MCL trial were overall response rate (ORR) and duration of response (DOR). Response was determined based on review of radiographic scans by an independent review committee according to a modified version of the International Workshop Lymphoma Response Criteria (Cheson, 1999). The DOR is defined as the time from the initial response (at least PR) to documented disease progression. The efficacy results for the MCL population were based on all eva luable patients who received at least one dose of study drug and are presented in Table 19. The median time to response was 2.2 months (range 1.8 to 13 months).
Table 19: Response Outcomes in the Pivotal Mantle Cell Lymphoma Trial
Response Analyses (N = 133) N (%) 95% CI
Overall Response Rate (IWRC) (CR + CRu +PR)
Complete Response (CR + CRu)
CR
CRu
Partial Response (PR) 34 (26)
9 (7)
1 (1)
8 (6)
25 (19) (18.4, 33.9)
(3.1, 12.5)
Duration of Response (months) Median 95% CI
Duration of Overall Response (CR + CRu + PR) (N = 34) 16.6 (7.7, 26.7)
15 REFERENCES
1. OSHA Hazardous Drugs. OSHA [Accessed on 29 January 2013, from http://www.osha.gov/SLTC/hazardousdrugs/index.html]
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1 How Supplied
White and blue-green opaque hard capsules imprinted “REV” on one half and “2.5 mg” on the other half in black ink:
2.5 mg bottles of 28 (NDC 59572-402-28)
2.5 mg bottles of 100 (NDC 59572-402-00)
White opaque capsules imprinted “REV” on one half and “5 mg” on the other half in black ink:
5 mg bottles of 28 (NDC 59572-405-28)
5 mg bottles of 100 (NDC 59572-405-00)
Blue/green and pale yellow opaque capsules imprinted “REV” on one half and “10 mg” on the other half in black ink:
10 mg bottles of 28 (NDC 59572-410-28)
10 mg bottles of 100 (NDC 59572-410-00)
Powder blue and white opaque capsules imprinted “REV” on one half and “15 mg” on the other half in black ink:
15 mg bottles of 21 (NDC 59572-415-21)
15 mg bottles of 100 (NDC 59572-415-00)
Powder blue and blue-green opaque hard capsules imprinted “REV” on one half and “20 mg” on t
