nd 1% received prior adjuvant or neoadjuvant therapy.
ARCHER 1050 demonstrated a statistically significant improvement in PFS as determined by the IRC. Results are summarized in Table 5 and Figures 1 and 2.
The hierarchical statistical testing order was PFS followed by ORR and then OS. No formal testing of OS was conducted since the formal comparison of ORR was not statistically significant.
Table 5. Efficacy Results in ARCHER 1050
VIZIMPRO
N=227 Gefitinib
N=225
CI=confidence interval; DoR=duration of response; HR=hazard ratio; IRC=Independent Radiologic Central; N/n=total number; PFS=progression-free survival.
*From stratified Cox Regression.
†Based on the stratified log-rank test.
‡Based on the stratified Cochran-Mantel-Haenszel test.
Progression-Free Survival (per IRC)
Number of patients with event, n (%) 136 (59.9%) 179 (79.6%)
Median PFS in months (95% CI) 14.7 (11.1, 16.6) 9.2 (9.1, 11.0)
HR (95% CI)* 0.59 (0.47, 0.74)
p-value† <0.0001
Overall Response Rate (per IRC)
Overall Response Rate % (95% CI) 75% (69, 80) 72% (65, 77)
p-value‡ 0.39
Duration of Response in Responders (per IRC)
Median DoR in months (95% CI) 14.8 (12.0, 17.4) 8.3 (7.4, 9.2)
Figure 1. Kaplan-Meier Curve for PFS per IRC Review in ARCHER 1050
Figure 1
Figure 2. Kaplan-Meier Curve for OS in ARCHER 1050
Figure 2
16 HOW SUPPLIED/STORAGE AND HANDLING
VIZIMPRO is supplied in strengths and package configurations as described in Table 6 below:
Table 6. VIZIMPRO Strengths and Package Configurations
VIZIMPRO Tablets
Package Configuration Tablet Strength (mg) NDC Tablet Description
30-Count Bottle with a child-resistant closure 15 0069-0197-30 Blue film-coated, immediate release, round biconvex tablet, debossed with "Pfizer" on one side and "DCB15" on the other side.
30-Count Bottle with a child-resistant closure 30 0069-1198-30 Blue film-coated immediate release, round biconvex tablet, debossed with "Pfizer" on one side and "DCB30" on the other side.
30-Count Bottle with a child-resistant closure 45 0069-2299-30 Blue film-coated immediate release, round biconvex tablet, debossed with "Pfizer" on one side and "DCB45" on the other side.
Store at 20 °C to 25 °C (68 °F to 77 °F); excursions permitted between 15 °C to 30 °C (59 °F to 86 °F). [see USP Controlled Room Temperature].
17 PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information).
Interstitial Lung Disease (ILD)
Advise patients of the risks of severe or fatal ILD, including pneumonitis. Advise patients to contact their healthcare provider immediately to report new or worsening respiratory symptoms [see Warnings and Precautions (5.1)].
Diarrhea
Advise patients to contact their healthcare provider at the first signs of diarrhea. Advise patients that intravenous hydration and/or anti-diarrheal medication (e.g., loperamide) may be required to manage diarrhea [see Warnings and Precautions (5.2)].
Dermatologic Adverse Reactions
Advise patients to initiate use of moisturizers and to minimize sun exposure with protective |
