Ramucirumab Approved for Advanced Colorectal Cancer

Roxanne Nelson, RN

Disclosures

April 28, 2015

The new angiogenesis inhibitor ramucirumab (Cyramza, Eli Lilly and Company) has been approved by the US Food and Drug Administration (FDA) for another indication, the treatment of colorectal cancer.

Ramucirumab is now approved for use in combination with FOLFIRI (folinic acid, 5-fluorouracil, and irinotecan) for the treatment of metastatic colorectal cancer in patients whose disease has progressed during or after therapy with bevacizumab (Avastin, Genentech BioOncology), oxaliplatin (Eloxatin, sanofi-aventis), and fluoropyrimidine.

Ramuricumab was first approved in April 2014 for use as a single agent or in combination with paclitaxel to treat patients with advanced or metastatic gastric cancer. That indication was extended in Novemeber 2014 to include gastroesophageal junction adenocarcinoma.

The drug was also approved in December 2014 for use in combination with docetaxel (multiple brands) for the treatment of patients with metastatic non–small cell lung cancer who experience disease progression during or after platinum-based chemotherapy.

"The FDA approvals for all four indications were received in just over a year," commented Sue Mahony, PhD, senior vice president and president, Lilly Oncology, in a statement.

Ramucirumab is a vascular endothelial growth factor receptor 2 (VEGFR) antagonist and is seen as a successor to the first angiogenesis inhibitor, bevacizumab.

Colorectal Cancer Study Results

The current approval is based on the results of the RAISE study, a phase 3 trial that compared ramucirumab plus FOLFIRI to placebo plus FOLFIRI in patients with metastatic colorectal cancer who experienced disease progression after prior therapy.

The trial included 1072 patients who were assigned in a 1:1 ratio to receive either FOLFIRI with placebo or FOLFIRI with ramucirumab. All patients had failed first-line treatment with bevacizumab and another standard chemotherapy (oxaliplatin plus a fluoropyrimidine).

Patients received either intravenous ramucirumab 8 mg/kg or placebo every 2 weeks until disease progression, unacceptable toxicity, or death.

Median overall survival, which was the study's primary endpoint, was longer in the ramucirumab group than in the placebo group (13.3 months vs 11.7 months; P = .0219). This translated into a hazard ratio (HR) of 0.84, showing that adding ramucirumab to the regimen reduced the risk for death by 16%.

Progression-free survival was also better in the ramucirumab group than in the placebo group (5.7 months vs 4.5 months; P = .0005), reducing the risk for progression by 21% (HR, 0.79).

Ramucirumab plus FOLFIRI was more toxic than placebo plus FOLFIRI, with a higher prevalence of grade 3 or high toxicities, including neutropenia (38.4% vs 23.3%), hypertension (11.2% vs. 2.8%), and diarrhea (10.8% vs 9.7%).

The labeling for ramuciumab contains boxed warnings for hemorrhage, gastrointestinal perforation, and impaired wound healing.

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