gger; in months (95% CI)
6.7 (6.3, 8.6)
4.7 (4.6, 5.6)
0.67 0.54, 0.81)
<0.0001
Median OS in months (95% CI)
20.1 (16.7, 23.4)
19.2 (17.5, 22.3)
0.97 (0.80, 1.17)
NS
ORR % (95% CI)
19.4 (15.4, 23.9)
9.4 (6.6, 12.9)
2.06 (1.41, 3.00)
PFS by prior treatment
Sunitinib-refractory subgroup
N=194
N=195
Median, months (95% CI)
4.8 (4.5, 6.4)
3.4 (2.8, 4.7)
0.74 (0.57, 0.96)
Cytokine-refractory subgroup
N=126
N=125
Median, months (95% CI)
12.1 (10.1, 13.9)
6.5 (6.3, 8.3)
0.46 (0.32, 0.68)
Figure 2. Kaplan-Meier Curve for Progression Free Survival by Independent Assessment (Intent-to-Treat Population)
16 HOW SUPPLIED/STORAGE AND HANDLING
INLYTA tablets are supplied as follows:
1 mg tablets are red film-coated, oval tablets debossed with "Pfizer" on one side and "1 XNB" on the other; available in bottles of 180: NDC 0069-0145-01.
5 mg tablets are red film-coated, triangular tablets debossed with "Pfizer" on one side and "5 XNB" on the other; available in bottles of 60: NDC 0069-0151-11.
Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].
17 PATIENT COUNSELING INFORMATION
See FDA Approved Patient Labeling
17.1 Hypertension
Advise patients that hypertension may develop during INLYTA treatment and that blood pressure should be monitored regularly during treatment [see Warnings and Precautions (5.1)].
17.2 Arterial/Venous Thromboembolic Events
Advise patients that arterial and venous thromboembolic events have been observed during INLYTA treatment and to inform their doctor if they experience symptoms suggestive of thromboembolic events [see Warnings and Precautions (5.2, 5.3)].
17.3 Hemorrhage
Advise patients that INLYTA may increase the risk of bleeding and to promptly inform their doctor of any bleeding episodes [see Warnings and Precautions (5.4)].
17.4 Gastrointestinal Disorders
Advise patients that gastrointestinal disorders such as diarrhea, nausea, vomiting, and constipation may develop during INLYTA treatment and to seek immediate medical attention if they experience persistent or severe abdominal pain because cases of gastrointestinal perforation and fistula have been reported in patients taking INLYTA [see Warnings and Precautions (5.5) and Adverse Reactions (6.1)].
17.5 Abnormal Thyroid Function
Advise patients that abnormal thyroid function may develop during INLYTA treatment and to inform their doctor if symptoms of abnormal thyroid function occur [see Warnings and Precautions (5.6)].
17.6 Wound Healing Complications
Advise patients to inform their doctor if they have an unhealed wound or if they have surgery scheduled [see Warnings and Precautions (5.7)].
17.7 Reversible Posterior Leukoencephalopathy Syndrome
Advise patients to inform their doctor if they have worsening of neurological function consistent with RPLS (headache, seizure, lethargy, confusion, blindness and other visual and neurologic disturbances) [see Warnings and Precautions (5.8)].
17.8 Pregnancy
Advise patients that INLYTA may cause birth defects or fetal loss and that they should not become pregnant during treatment with INLYTA. Both male and female patients should be counseled to use effective birth control during treatment with I |
