FDA Approves Cyramza for Gastric Cancer

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FDA Approves Cyramza for Gastric Cancer
FDA Approves Cyramza for Gastric Cancer

« EXPERT OPINION »
Alexandria Phan, MD, Richard M. Goldberg, MD, and Rachel Webster, DPhil, MSc, provide additional insight on this topic. Click here for more.

« RELATED FROM THE ADVISORY BOARD »
Steven J. Cohen, MD, member of the Chemotherapy Advisor Editorial Board, weighs in on the FDA's decision to approve Cyramza (ramucirumab). Click here for more

Eli Lilly and Company announced that the FDA has approved Cyramza (ramucirumab) 10mg/mL injection for the treatment of patients with advanced or metastatic gastric cancer or gastroesophageal junction (GEJ) adenocarcinoma with disease progression on or after prior fluoropyrimidine- or platinum-containing chemotherapy.

Cyramza, the first FDA-approved treatment for patients in this setting, is a human vascular endothelial growth factor (VEGF) Receptor 2 antagonist that specifically inhibits the binding of VEGF receptor ligands VEGF-A, VEGF-C, and VEGF-D by binding to VEGF Receptor 2.

RELATED: Gastrointestinal Cancers Resource Center

The approval was based on the REGARD trial, a multicenter, randomized, placebo-controlled, double-blind clinical trial of 355 patients with locally advanced or metastatic gastric cancer or GEJ adenocarcinoma previously treated with fluoropyrimidine- or platinum-containing chemotherapy. This was the first Phase 3 trial to demonstrate improvement in overall survival and progression-free survival with a biologic agent in advanced gastric cancer after prior chemotherapy.

Participants that received Cyramza 8mg/kg by infusion every two weeks plus best supportive care (BSC) vs. those that received placebo plus BSC, ddemonstrated an increased median overall survival by 37% (median overall survival of 5.2 months [95% confidence interval (CI) 4.4, 5.7] vs. 3.8 months [95% CI 2.8, 4.7] for placebo, P=0.047, hazard ratio 0.78 [95% CI 0.60, 0.998]). Additionally, Cyramza significantly improved progression-free survival, demonstrating a 62% increase in median progression-free survival (2.1 months [95% CI 1.5, 2.7] vs. 1.3 months [95% CI 1.3, 1.4] for placebo, P<0.001, hazard ratio 0.48 [95% CI 0.38, 0.62]).

Cyramza will be available in 100mg/10mL and 500mg/50mL strengths in single-dose vials.

For more information call (800) 545-5979 or visit Lilly.com.


Expert Opinion
Alexandria Phan, MD
Alexandria Phan, MD
Ramucirumab is a fully humanized monoclonal antibody against the vascular endothelial growth factor receptor 2 (VEGFR2). This is a biological agent that has been tested in several cancers including stomach and lung cancers. On Monday, the FDA approved this agent for the treatment of patients with advanced gastric or gastro-esophageal junction cancers.

Ramucirumab's safety and effectiveness were evaluated in a clinical trial of 355 participants with inoperable or metastatic stomach or gastroesophageal junction cancer. The trial was designed to measure the length of time participants lived before death (overall survival)... Read more


Alexandria Phan, MD
Gastrointestinal Medical Oncology Director
Medical Oncologist, Houston Methodist Hospital
Houston Methodist Cancer Center
Houston, TX


Expert Opinion
Richard M. Goldberg, MD
Richard M. Goldberg, MD
The approval of ramucirumab as a single agent for the treatment of patients with metastatic gastric cancer is significant for many reasons.

Gastric cancer is the fourth leading cause of cancer death worldwide. Treatment for patients with advanced gastric cancer has been limited to chemotherapy except in the minority of cases where the tumor cells overexpress HER-2. In those cases, trastuzumab plus chemotherapy can be beneficial. Patients with advanced gastric cancer often are older and symptomatic from their cancers, making combination chemotherapy difficult for them to tolerate.

Ramucirumab targets blood vessel growth and is effective as a single agent. As a targeted therapy rather than chemotherapy its main side effect was hypertension, a condition readily amenable to treatment... Read more


Richard M. Goldberg, MD
Physician-in-Chief
James Cancer Hospital
Professor of Medicine
The James Comprehensive Cancer Center at Ohio State University
Columbus, OH


Expert Opinion
Rachel Webster, DPhil, MSc
Rachel Webster, DPhil, MSc
Two positive phase 3 studies of ramucirumab (REGARD and RAINBOW) and the recent FDA approval of ramucirumab as a single agent (based on results from the REGARD trial) confirm that there is a role for angiogenesis inhibitors in treating gastric cancer. These positive data have reignited interviewed physicians' enthusiasm for this class of agents in gastric cancer, and ramucirumab is a welcome new biologic addition to the gastric treatment armamentarium.

Worth noting is the fact that ramucirumab is the first targeted therapy to secure regulatory approval for patients with advanced or metastatic gastric cancer who have progressed on or following fluoropyrimidine- or platinum-containing chemotherapy (i.e., second- and later-line treatment). This is a patient population for which treatments are extremely limited.

There is no universal standard second- or later-line chemotherapy for gastric cancer, and administering therapy in these patients is particularly challenging given the aggressive nature of the disease and patients' rapidly declining performance status. A sizable proportion of patients in the second- and later-line settings will receive best supportive care (BSC) only or be enrolled in a clinical trial... Read more


Rachel Webster, DPhil, MSc
Senior Director of Oncology
Decision Resources Group
Burlington, MA


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