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Ramucirumab, a human vascular endothelial growth factor receptor 2 antagonist, has been approved as a treatment for people with advanced gastric cancer or gastroesophageal junction adenocarcinoma, the Food and Drug Administration announced on April 21.
It is intended for use as a single-agent treatment after prior fluoropyrimidine- or platinum-containing chemotherapy, and is administered intravenously every 2 weeks, according to the prescribing information.
Ramucirumab "is a new treatment option that has demonstrated an ability to extend patients’ lives and slow tumor growth," Dr. Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, said in the FDA’s statement announcing approval.
Approval was based on a study of 355 people with unresectable or metastatic stomach or gastroesophageal junction cancer. The median overall survival among those treated with ramucirumab was 5.2 months, compared with 3.8 months among those on placebo, according to the FDA statement. The hazard ratio was 0.78 (P = .047). Progression-free survival also favored those on ramucirumab: 2.1 vs 1.3 months among those on placebo, which was statistically significant (HR, 0.48). In a second study that compared treatment with ramucirumab plus paclitaxel, to paclitaxel alone, overall survival also favored those in the group treated with the combination.
Diarrhea and hypertension were common adverse events associated with treatment in clinical trials. The prescribing information includes a boxed warning about the increased risk of hemorrhage, including severe and sometimes fatal hemorrhagic events.
The FDA statement cited National Cancer Institute estimates that 22,220 Americans will be diagnosed with stomach cancer and 10,990 will die of stomach cancer this year. "Although the rates of stomach cancer in the United States have decreased over the past 40 years, patients require new treatment options, particularly when they no longer respond to other therapies," Dr. Pazdur said in the statement.
Ramucirumab, which was granted orphan drug status because stomach cancer is a rare disease, was granted a priority review; it will be marketed as Cyramza by Eli Lilly.
Ramucirumab, a human vascular endothelial growth factor receptor 2 antagonist, has been approved as a treatment for people with advanced gastric cancer or gastroesophageal junction adenocarcinoma, the Food and Drug Administration announced on April 21.
It is intended for use as a single-agent treatment after prior fluoropyrimidine- or platinum-containing chemotherapy, and is administered intravenously every 2 weeks, according to the prescribing information.
Ramucirumab "is a new treatment option that has demonstrated an ability to extend patients’ lives and slow tumor growth," Dr. Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, said in the FDA’s statement announcing approval.
Approval was based on a study of 355 people with unresectable or metastatic stomach or gastroesophageal junction cancer. The median overall survival among those treated with ramucirumab was 5.2 months, compared with 3.8 months among those on placebo, according to the FDA statement. The hazard ratio was 0.78 (P = .047). Progression-free survival also favored those on ramucirumab: 2.1 vs 1.3 months among those on placebo, which was statistically significant (HR, 0.48). In a second study that compared treatment with ramucirumab plus paclitaxel, to paclitaxel alone, overall survival also favored those in the group treated with the combination.
Diarrhea and hypertension were common adverse events associated with treatment in clinical trials. The prescribing information includes a boxed warning about the increased risk of hemorrhage, including severe and sometimes fatal hemorrhagic events.
The FDA statement cited National Cancer Institute estimates that 22,220 Americans will be diagnosed with stomach cancer and 10,990 will die of stomach cancer this year. "Although the rates of stomach cancer in the United States have decreased over the past 40 years, patients require new treatment options, particularly when they no longer respond to other therapies," Dr. Pazdur said in the statement.
Ramucirumab, which was granted orphan drug status because stomach cancer is a rare disease, was granted a priority review; it will be marketed as Cyramza by Eli Lilly.
Ramucirumab, a human vascular endothelial growth factor receptor 2 antagonist, has been approved as a treatment for people with advanced gastric cancer or gastroesophageal junction adenocarcinoma, the Food and Drug Administration announced on April 21.
It is intended for use as a single-agent treatment after prior fluoropyrimidine- or platinum-containing chemotherapy, and is administered intravenously every 2 weeks, according to the prescribing information.
Ramucirumab "is a new treatment option that has demonstrated an ability to extend patients’ lives and slow tumor growth," Dr. Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, said in the FDA’s statement announcing approval.
Approval was based on a study of 355 people with unresectable or metastatic stomach or gastroesophageal junction cancer. The median overall survival among those treated with ramucirumab was 5.2 months, compared with 3.8 months among those on placebo, according to the FDA statement. The hazard ratio was 0.78 (P = .047). Progression-free survival also favored those on ramucirumab: 2.1 vs 1.3 months among those on placebo, which was statistically significant (HR, 0.48). In a second study that compared treatment with ramucirumab plus paclitaxel, to paclitaxel alone, overall survival also favored those in the group treated with the combination.
Diarrhea and hypertension were common adverse events associated with treatment in clinical trials. The prescribing information includes a boxed warning about the increased risk of hemorrhage, including severe and sometimes fatal hemorrhagic events.
The FDA statement cited National Cancer Institute estimates that 22,220 Americans will be diagnosed with stomach cancer and 10,990 will die of stomach cancer this year. "Although the rates of stomach cancer in the United States have decreased over the past 40 years, patients require new treatment options, particularly when they no longer respond to other therapies," Dr. Pazdur said in the statement.
Ramucirumab, which was granted orphan drug status because stomach cancer is a rare disease, was granted a priority review; it will be marketed as Cyramza by Eli Lilly.
