ian 11.0 13.5
95% CI (mos.) (9.4, 12.5) (11.7, 15.7)
Hazard Ratio 0.73
95% CI (0.60, 0.91)
p value*
, two sided 0.0038
Updated Overall Survival
No. Deaths (%) 227 (76.7%) 221 (74.2%)
Median 11.7 13.1
95% CI (mos.) (10.3, 13.0) (11.9, 15.1)
Hazard Ratio 0.80
95% CI (0.67, 0.97)
* Comparing with the nominal significance level of 0.0193.
Figure 7
Updated Overall Survival in Patients with Metastatic Gastric Cancer (Study 7)An exploratory analysis of OS in patients based on HER2 gene amplification (FISH) and protein overexpression(IHC) testing is summarized in Table 14.
Table 14
Exploratory Analyses by HER2 Status Using Updated Overall Survival Results
FC FC + H
(N = 296)a (N = 298)b
FISH+ / IHC 0, 1+ subgroup (N = 133)
No. Deaths / n (%) 57/71 (80%) 56/62 (90%)
Median OS Duration (mos.) 8.8 8.3
95% CI (mos.) (6.4, 11.7) (6.2, 10.7)
Hazard ratio (95% CI) 1.33 (0.92, 1.92)
FISH+ / IHC2+ subgroup (N = 160)
No. Deaths / n (%) 65/80 (81%) 64/80 (80%)
Median OS Duration (mos.) 10.8 12.3
95% CI (mos.) (6.8, 12.8) (9.5, 15.7)
Hazard ratio (95% CI) 0.78 (0.55, 1.10)
FISH+ or FISH- / IHC 3+c
subgroup (N = 294)
No. Deaths / n (%) 104/143 (73%) 96/151 (64%)
Median OS Duration (mos.) 13.2 18.0
95% CI (mos.) (11.5, 15.2) (15.5, 21.2)
Hazard ratio (95% CI) 0.66 (0.50, 0.87)
a Two patients on the FC arm who were FISH+ but IHC status unknown were excluded from theexploratory subgroup analyses.
b Five patients on the trastuzumab-containing arm who were FISH+, but IHC status unknown were excludedfrom the exploratory subgroup analyses. c Includes 6 patients on chemotherapy arm, 10 patients on trastuzumab arm with FISH-, IHC 3+ and 8 patients onchemotherapy arm, 8 patients on trastuzumab arm with FISH status unknown, IHC 3+.
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1 How Supplied
KANJINTI (trastuzumab-anns) for injection 420 mg/vial is supplied in a multiple-dose vial as a white to paleyellow lyophilized sterile powder, under vacuum. Each carton contains one multiple-dose vial of KANJINTI.
NDC 55513-132-01.
16.2 Stability and Storage
Store KANJINTI vials in the original carton to protect from light in the refrigerator at 2°C to 8°C (36°F to 46°F)until time of reconstitution.
17 PATIENT COUNSELING INFORMATION
Cardiomyopathy
Advise patients to contact a health care professional immediately for any of the following: new onsetor worsening shortness of breath, cough, swelling of the ankles/legs, swelling of the face, palpitations,weight gain of more than 5 pounds in 24 hours, dizziness or loss of consciousness [see Boxed Warning: Cardiomyopathy].
Embryo-Fetal ToxicityAdvise pregnant women and females of reproductive potential that KANJINTI exposure during pregnancyor within 7 months prior to conception can result in fetal harm. Advise female patients to contact theirhealthcare provider with a known or suspected pregnancy [see Use in Specific Populations (8.1)].
Advise females of reproductive potential to use effective contraception during treatment and for 7 monthsfollowing the last dose of KANJINTI [see Use in Specific Populations (8.3)].
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761073s000lbl.p
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