rvival
(independent review)
Number (%) of patients with event 265 (53.5%) 304 (61.3%)
Median duration of PFS (months) 9.6 6.4
Hazard Ratio (stratified*) 0.650
95% CI for Hazard Ratio (0.549, 0.771)
p-value (Log-Rank test, stratified*) <0.0001
Overall Survival †
Number (%) of patients who died 149 (30.1%) 182 (36.7%)
Median duration of survival (months) 30.9 25.1
Hazard Ratio (stratified*) 0.682
95% CI for Hazard Ratio (0.548, 0.849)
p-value (Log-Rank test*) 0.0006
Objective Response Rate
(independent review)
Patients with measurable disease 397 389
Number of patients with OR (%) 173 (43.6%) 120 (30.8%)
Difference (95% CI) 12.7% (6.0, 19.4)
Duration of Objective Response (months)
Number of patients with OR 173 120
Median duration (95% CI) 12.6 (8.4, 20.8) 6.5 (5.5, 7.2)
Figure 1 Kaplan-Meier Curve of IRC-Assessed Progression-Free Survival for Study 1
Figure 2 Kaplan-Meier Curve of Overall Survival for Study 1
REFERENCES
OSHA Hazardous Drugs. OSHA. http://www.osha.gov/SLTC/hazardousdrugs/index.html
How Supplied/Storage and Handling
How Supplied/Storage
Kadcyla (ado-trastuzumab emtansine) is supplied as:
Carton Contents NDC
One 100 mg vial, single use vial NDC 50242-088-01
One 160 mg vial, single use vial NDC 50242-087-01
Store vials in a refrigerator at 2°C to 8°C (36°F to 46°F) until time of reconstitution. Do not freeze or shake.
Special Handling
Follow procedures for proper handling and disposal of anticancer drugs1.
Patient Counseling Information
Inform patients of the possibility of severe liver injury and advise patients to immediately seek medical attention if they experience symptoms of acute hepatitis such as nausea, vomiting, abdominal pain (especially RUQ abdominal pain), jaundice, dark urine, generalized pruritus, anorexia, etc. [see Warnings and Precautions (5.1)].
Advise patients to contact a health care professional immediately for any of the following: new onset or worsening shortness of breath, cough, swelling of the ankles/legs, palpitations, weight gain of more than 5 pounds in 24 hours, dizziness or loss of consciousness [see Warnings and Precautions (5.2)].
Advise pregnant women and females of reproductive potential that Kadcyla exposure can result in fetal harm, including embryo-fetal death or birth defects [see Warnings and Precautions (5.3), Use in Specific Populations (8.1, 8.6)].
Advise females of reproductive potential to use effective contraception while receiving Kadcyla and for 6 months following the last dose of Kadcyla [See Warnings and Precautions (5.3) and Use in Specific Populations (8.1, 8.6)].
Advise nursing mothers treated with Kadcyla to discontinue nursing or discontinue Kadcyla, taking into account the importance of the drug to the mother [see Use in Specific Populations (8.3)].
Encourage women who are exposed to Kadcyla during pregnancy to enroll in the MotHER Pregnancy Registry by contacting 1-800-690-6720 [see Warnings and Precautions (5.3) and Use in Specific Populations (8.1, 8.6)].
Kadcyla™ [ado-trastuzumab emtansine]
4862200
Manufactured by: Initial U.S. Approval: February 2013
Genentech, Inc.
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