US regulators have issued a second approval for Eli Lilly’s Cyramza (ramucirumab) to treat gastric cancers, allowing its use alongside the chemotherapy paclitaxel to improve survival.
The US Food and Drug Administration has cleared the regimen to treat patients with advanced or metastatic gastric (stomach) or gastroesophageal junction (GEJ) adenocarcinoma, when the disease has progressed despite prior fluoropyrimidine- or platinum-containing chemo.
Stomach cancer is the fifth most common cancer in the world, with around 22,000 diagnoses expected this year in the US alone. According to Lilly, Cyramza, which was first cleared by the FDA in April as a standalone agent and also carries orphan drug status, is the only approved second-line treatment option for US patients.
Approval came on the back of data from the Phase III Rainbow trial showing that adding Cyramza to paclitaxel induced a significant improvement in overall survival, progression-free survival and response rate.
Patients taking the regimen had a median survival benefit of 9.6 months compared to 7.4 months for those in the control arm, while Lilly’s regimen also significantly cut the risk of disease progression or death (by 37%), with a 52% increase in median progression-free survival compared with placebo (4.4 months vs. 2.9 months).