re White and 20% Asian; 49% had ECOG PS 0; 49% of patients had KRAS mutant tumors; and 24% of patients had <6 months from time to disease progression after beginning first-line treatment.
Overall survival and progression-free survival were statistically significantly improved in patients randomized to receive CYRAMZA plus FOLFIRI compared to patients randomized to receive placebo plus FOLFIRI. The treatment effect was consistent across the pre-specified stratification factors. Efficacy results are shown in Table 9 and Figure 4.
Table 9: Randomized Trial of CYRAMZA plus FOLFIRI versus Placebo plus FOLFIRI in mCRC
Abbreviations: CI = confidence interval.
Figure 4: Kaplan-Meier Curve of Overall Survival - CYRAMZA plus FOLFIRI versus Placebo plus FOLFIRI in mCRC
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1 How Supplied
CYRAMZA is supplied in single-dose vials as a sterile, preservative-free solution.
NDC 0002-7669-01
100 mg/10 mL (10 mg/mL), individually packaged in a carton
NDC 0002-7678-01
500 mg/50 mL (10 mg/mL), individually packaged in a carton
16.2 Storage and Handling
Store vials in a refrigerator at 2°C to 8°C (36°F to 46°F) until time of use. Keep the vial in the outer carton in order to protect from light. DO NOT FREEZE OR SHAKE the vial.
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c6080942-dee6-423e-b688-1272c2ae90d4 |
