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Cyramza Summary of Product Characteristics (SmPC)
Cyramza® (ramucirumab): Safety on Use in Combination with FOLFIRI in Patients with Metastatic Colorectal Cancer
The most common all-grade AEs in patients who were treated with Cyramza (ramucirumab) were diarrhea, neutropenia, decreased appetite, epistaxis, and stomatitis.
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
grade TEAEs that occurred in ≥20% of patients in either treatment
arm and grade ≥3 TEAEs are presented in Table
1. Any Grade TEAEs That Occurred in ≥20% of Patients in Either
Treatment Arm and Grade ≥3 TEAEs1,2
FOLFIRI = irinotecan, folinic acid, and 5-fluorouracil; MedDRA
= Medical Dictionary for Regulatory Activities; NA = not
applicable; NCI-CTC = National Cancer Institute Common Terminology
Criteria; TEAEs = treatment‑emergent adverse events.
The rate of any grade of febrile neutropenia was 4% in the
ramucirumab + FOLFIRI group and 3% in the FOLFIRI + placebo group.
Consolidated category comprising synonymous MedDRA preferred
terms or adverse event of special interest grouping.
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.
Data on file, Eli Lilly and Company and/or one of its subsidiaries.
= irinotecan, folinic acid, and 5-fluorouracil
= Kirsten rat sarcoma viral oncogene
= metastatic colorectal cancer
= treatment-emergent adverse event
Date of Last Review:January 24, 2020
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