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Cyramza Summary of Product Characteristics (SmPC)
Cyramza® (ramucirumab): Adverse Event During Prior Bevacizumab in RAISE
During enrollment in RAISE, patients who had certain AEs during prior bevacizumab were excluded from participation and receiving Cyramza® (ramucirumab).
RAISE trial was a phase 3, multicenter, randomized, double-blind,
placebo-controlled trial that evaluated FOLFIRI and ramucirumab vs
FOLFIRI and placebo in the second-line treatment of patients with
mCRC who had progressed on first-line combination therapy with
bevacizumab, oxaliplatin, and a fluoropyrimidine. Patients were
randomly assigned in a 1:1 ratio (stratified by region, KRAS mutation
status, and time to PD after beginning first-line treatment) to
receive IV infusions of either FOLFIRI plus ramucirumab 8 mg/kg
(n=536) or FOLFIRI plus placebo (n=536) once every 2 weeks.1
were excluded from participation if during prior treatment with
bevacizumab they had experienced
Tabernero J, Yoshino T, Cohn AL, et al. Ramucirumab versus placebo
in combination with second-line FOLFIRI in patients with metastatic
colorectal carcinoma that progressed during or after first-line
therapy with bevacizumab, oxaliplatin, and a fluoropyrimidine
(RAISE): a randomised, double-blind, multicentre, phase 3 study.
Lancet Oncol. 2015;16(5):499-508.
= irinotecan, folinic acid, and 5-fluorouracil
= Kirsten rat sarcoma viral oncogene
= metastatic colorectal cancer
Date of Last Review:May 19, 2020
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