with two modifications to align with the updated 2014 NIH Consensus Panel Response Criteria. Efficacy results are shown in TABLE 22.
Table 22: Best Overall Response Rate (ORR) and Sustained Response Rate Based on Investigator Assessmenta in Patients with cGVHD in Study 1129
Total (N=42)
CI = confidence interval
a Investigator assessment based on the 2005 NIH Response Criteria with two modifications (added "not eva luable" for organs with non-cGVHD abnormalities, and organ score change from 0 to 1 was not considered disease progression)
b Sustained response rate is defined as the proportion of patients who achieved a CR or PR that was sustained for at least 20 weeks.
ORR 28 (67%)
95% CI (51%, 80%)
Complete Response (CR) 9 (21%)
Partial Response (PR) 19 (45%)
Sustained response rateb 20 (48%)
The median time to response coinciding with the first scheduled response assessment was 12.3 weeks (range, 4.1 to 42.1 weeks). Responses were seen across all organs involved for cGVHD (skin, mouth, gastrointestinal tract, and liver).
ORR results were supported by exploratory analyses of patient-reported symptom bother which showed at least a 7-point decrease in Lee Symptom Scale overall summary score in 24% (10/42) of patients on at least 2 consecutive visits.
16 HOW SUPPLIED/STORAGE AND HANDLING
The 70 mg capsules are supplied as yellow opaque capsules, marked with "ibr 70 mg" in black ink, and are available in white HDPE bottles with a child-resistant closure:
28 capsules per bottle: NDC 57962-070-28
The 140 mg capsules are supplied as white opaque capsules, marked with "ibr 140 mg" in black ink, and are available in white HDPE bottles with a child-resistant closure:
90 capsules per bottle: NDC 57962-140-09
120 capsules per bottle: NDC 57962-140-12
Store bottles at room temperature 20°C to 25°C (68°F to 77°F). Excursions are permitted between 15°C and 30°C (59°F to 86°F). Retain in original package until dispensing.
The IMBRUVICA (ibrutinib) tablets are supplied in 4 strengths in the following packaging configurations:
140 mg tablets: Yellow green to green round tablets debossed with "ibr" on one side and "140" on the other side. Carton of one folded blister card containing two 14-count blister strips for a total of 28 tablets: NDC 57962-014-28
280 mg tablets: Purple oblong tablets debossed with "ibr" on one side and "280" on the other side. Carton of one folded blister card containing two 14-count blister strips for a total of 28 tablets: NDC 57962-280-28
420 mg tablets: Yellow green to green oblong tablets debossed with "ibr" on one side and "420" on the other side. Carton of one folded blister card containing two 14-count blister strips for a total of 28 tablets: NDC 57962-420-28
560 mg tablets: Yellow to orange oblong tablets debossed with "ibr" on one side and "560" on the other side. Carton of one folded blister card containing two 14-count blister strips for a total of 28 tablets: NDC 57962-560-28
Store tablets in original packaging at room temperature 20°C to 25°C (68°F to 77°F). Excursions are permitted between 15°C and 30°C (59°F to 86°F).
17 PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information).
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