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The Food and Drug Administration has expanded approval of the antiangiogenic agent ramucirumab for use in combination with FOLFIRI for “the treatment of metastatic colorectal cancer (mCRC) with disease progression on or after prior therapy with bevacizumab, oxaliplatin, and a fluoropyrimidine,” according to the updated prescribing information.
The FDA announced the expanded approval on April 24 in a statement, which said that it was based on the results of an international study of 1,072 patients with mCRC that progressed during or within 6 months of discontinuing bevacizumab-, oxaliplatin- and fluoropyrimidine-based combination chemotherapy, randomized to treatment with FOLFIRI alone, or to FOLFIRI plus ramucirumab. Their median age was 62 years, almost 60% were men, and 99% had an ECOG performance status of 0 or 1. In both arms, treatment was administered every 2 weeks; the dose of ramucirumab was 8mg/kg, administered by an intravenous infusion every 2 weeks, and was continued until disease progressed or toxicity became unacceptable.
Median overall survival (OS), the primary endpoint, was 13.3 months among those on ramucirumab, vs. 11.7 months among those on placebo. The improvement in OS was statistically significant (P = .023), with a reduced risk of 15%. Compared with those on FOLFIRI alone, there was also a significant improvement in progression-free survival (PFS) among those treated with the combination, a median of 5.7 months vs. 4.5 months (P < 0.001) and a reduced risk of 21%.
“In general, the safety data was consistent with the known safety profile established in previously approved indications,” although thyroid monitoring identified hypothyroidism in 2.6% of patients, according to the statement. The label includes a boxed warning about the risks of hemorrhage, gastrointestinal perforation, and impaired wound healing associated with treatment.
Ramucirumab is a human vascular endothelial growth factor receptor 2 (VEGFR2) antagonist, marketed as Cyramza by Eli Lilly. It was initially approved for advanced gastric cancer and gastroesophageal junction adenocarcinoma, and metastatic non–small cell lung cancer indications in late 2014.
Serious adverse events associated with treatment should be reported to the FDA’s MedWatch program at 800-332-1088 or online https://www.accessdata.fda.gov/scripts/medwatch/.
The Food and Drug Administration has expanded approval of the antiangiogenic agent ramucirumab for use in combination with FOLFIRI for “the treatment of metastatic colorectal cancer (mCRC) with disease progression on or after prior therapy with bevacizumab, oxaliplatin, and a fluoropyrimidine,” according to the updated prescribing information.
The FDA announced the expanded approval on April 24 in a statement, which said that it was based on the results of an international study of 1,072 patients with mCRC that progressed during or within 6 months of discontinuing bevacizumab-, oxaliplatin- and fluoropyrimidine-based combination chemotherapy, randomized to treatment with FOLFIRI alone, or to FOLFIRI plus ramucirumab. Their median age was 62 years, almost 60% were men, and 99% had an ECOG performance status of 0 or 1. In both arms, treatment was administered every 2 weeks; the dose of ramucirumab was 8mg/kg, administered by an intravenous infusion every 2 weeks, and was continued until disease progressed or toxicity became unacceptable.
Median overall survival (OS), the primary endpoint, was 13.3 months among those on ramucirumab, vs. 11.7 months among those on placebo. The improvement in OS was statistically significant (P = .023), with a reduced risk of 15%. Compared with those on FOLFIRI alone, there was also a significant improvement in progression-free survival (PFS) among those treated with the combination, a median of 5.7 months vs. 4.5 months (P < 0.001) and a reduced risk of 21%.
“In general, the safety data was consistent with the known safety profile established in previously approved indications,” although thyroid monitoring identified hypothyroidism in 2.6% of patients, according to the statement. The label includes a boxed warning about the risks of hemorrhage, gastrointestinal perforation, and impaired wound healing associated with treatment.
Ramucirumab is a human vascular endothelial growth factor receptor 2 (VEGFR2) antagonist, marketed as Cyramza by Eli Lilly. It was initially approved for advanced gastric cancer and gastroesophageal junction adenocarcinoma, and metastatic non–small cell lung cancer indications in late 2014.
Serious adverse events associated with treatment should be reported to the FDA’s MedWatch program at 800-332-1088 or online https://www.accessdata.fda.gov/scripts/medwatch/.
The Food and Drug Administration has expanded approval of the antiangiogenic agent ramucirumab for use in combination with FOLFIRI for “the treatment of metastatic colorectal cancer (mCRC) with disease progression on or after prior therapy with bevacizumab, oxaliplatin, and a fluoropyrimidine,” according to the updated prescribing information.
The FDA announced the expanded approval on April 24 in a statement, which said that it was based on the results of an international study of 1,072 patients with mCRC that progressed during or within 6 months of discontinuing bevacizumab-, oxaliplatin- and fluoropyrimidine-based combination chemotherapy, randomized to treatment with FOLFIRI alone, or to FOLFIRI plus ramucirumab. Their median age was 62 years, almost 60% were men, and 99% had an ECOG performance status of 0 or 1. In both arms, treatment was administered every 2 weeks; the dose of ramucirumab was 8mg/kg, administered by an intravenous infusion every 2 weeks, and was continued until disease progressed or toxicity became unacceptable.
Median overall survival (OS), the primary endpoint, was 13.3 months among those on ramucirumab, vs. 11.7 months among those on placebo. The improvement in OS was statistically significant (P = .023), with a reduced risk of 15%. Compared with those on FOLFIRI alone, there was also a significant improvement in progression-free survival (PFS) among those treated with the combination, a median of 5.7 months vs. 4.5 months (P < 0.001) and a reduced risk of 21%.
“In general, the safety data was consistent with the known safety profile established in previously approved indications,” although thyroid monitoring identified hypothyroidism in 2.6% of patients, according to the statement. The label includes a boxed warning about the risks of hemorrhage, gastrointestinal perforation, and impaired wound healing associated with treatment.
Ramucirumab is a human vascular endothelial growth factor receptor 2 (VEGFR2) antagonist, marketed as Cyramza by Eli Lilly. It was initially approved for advanced gastric cancer and gastroesophageal junction adenocarcinoma, and metastatic non–small cell lung cancer indications in late 2014.
Serious adverse events associated with treatment should be reported to the FDA’s MedWatch program at 800-332-1088 or online https://www.accessdata.fda.gov/scripts/medwatch/.
