OS in months (95% CI) 25.5 (16.4, 32.1) 15.4 (11.8, 20.6)
Hazard Ratio (95% CI)b
LENVIMA + Everolimus vs Everolimus 0.67 (0.42, 1.08)
-
Objective Response Rate (Confirmed)
Objective response rate, n (%) 19 (37) 3 (6)
(95% CI) (24, 52) (1, 17)
Number of complete responses, n (%) 1 (2) 0
Number of partial responses (%) 18 (35) 3 (6)
Tumor assessments were based on RECIST v1.1 criteria for progression but only confirmed responses are included for ORR. Data cutoff date = 13 Jun 2014
CI = confidence interval
a Point estimates are based on Kaplan-Meier method and 95% CIs are based on the Greenwood formula using log-log transformation.
b Hazard ratio is based on a stratified Cox regression model including treatment as a covariate factor and hemoglobin and corrected serum calcium as strata.
c Data cutoff date = 31 Jul 2015
Figure 2: Kaplan-Meier Plot of Progression-Free Survival (Investigator Assessment-Study 2)
Figure 2: Kaplan-Meier Plot of Progression-Free Survival (Investigator Assessment-Study 2)
Figure 3: Kaplan-Meier Plot of Overall Survival (Study 2)
Figure 3: Kaplan-Meier Plot of Overall Survival (Study 2)
16 HOW SUPPLIED/STORAGE AND HANDLING
LENVIMA 4 mg capsules are supplied as hard hypromellose capsules with yellowish-red body and yellowish-red cap, marked in black ink with “Є” on the cap and “LENV 4 mg” on the body.
LENVIMA 10 mg capsules are supplied as hard hypromellose capsules with yellow body and yellowish-red cap, marked in black ink with “Є” on the cap and “LENV 10 mg” on the body.
LENVIMA capsules are supplied in cartons of 6 cards. Each card is a 5-day blister card as follows:
NDC 62856-724-30: 24 mg, carton with 6 cards NDC 62856-724-05 (ten 10 mg capsules and five 4 mg capsules per card).
NDC 62856-720-30: 20 mg, carton with 6 cards NDC 62856-720-05 (ten 10 mg capsules per card).
NDC 62856-718-30: 18 mg, carton with 6 cards NDC 62856-718-05 (five 10 mg capsules and ten 4 mg capsules per card).
NDC 62856-714-30: 14 mg, carton with 6 cards NDC 62856-714-05 (five 10 mg capsules and five 4 mg capsules per card).
NDC 62856-710-30: 10 mg, carton with 6 cards NDC 62856-710-05 (five 10 mg capsules per card).
NDC 62856-708-30: 8 mg, carton with 6 cards NDC 62856-708-05 (ten 4 mg capsules per card).
Store at 25°C (77°F); excursions permitted to 15 – 30°C (59 – 86°F) [see USP Controlled Room Temperature].
17 PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information).
Hypertension:
Advise patients to undergo regular blood pressure monitoring and to contact their health care provider if blood pressure is elevated [see WARNINGS AND PRECAUTIONS (5.1)].
Cardiac Dysfunction:
Advise patients that LENVIMA can cause cardiac dysfunction and to immediately contact their healthcare provider if they experience any clinical symptoms of cardiac dysfunction such as shortness of breath or swelling of ankles [see WARNINGS AND PRECAUTIONS (5.2)].
Arterial Thrombotic Events:
Advise patients to seek immediate medical attention for new onset chest pain or acute neurologic symptoms consistent with myocardial infarction or stroke [see WARNINGS AND PRECAUTIONS (5.3)].
Hepatotoxicity:
Advise patients tha |
