The Food and Drug Administration has approved the use of ramucirumab, a human vascular endothelial growth factor receptor 2 antagonist, in combination with paclitaxel as a treatment for patients with advanced or metastatic gastric or gastroesophageal junction adenocarcinoma whose cancer has progressed on or after prior fluoropyrimidine- or platinum-containing chemotherapy, according to a letter from the FDA to the company. This follows the April approval of ramucirumab as a single agent for these patients.
Ramucirumab, which was granted orphan drug status, had been granted a priority review and is being marketed as Cyramza by Eli Lilly.
Ramucirumab is the only FDA-approved second-line treatment option for patients with advanced or metastatic gastric or gastroesophageal junction adenocarcinoma whose disease has progressed on or after prior fluoropyrimidine- or platinum-containing chemotherapy, according to a company press release announcing the expanded approval.
This approval is based on the phase III RAINBOW (Ramucirumab in Metastatic Gastric Adenocarcinoma) trial, which randomized 665 patients to receive ramucirumamb plus paclitaxel or placebo plus paclitaxel.
Adding ramucirumab prolonged overall survival, the trial’s primary endpoint, by more than 2 months, first author Dr. Hansjochen Wilke, director of the department of oncology, hematology, and center of palliative care at Kliniken Essen-Mitte, Germany, reported during a presscast in advance of the annual Gastrointestinal Cancers Symposium in January.
The prescribing information for ramucirumab contains a boxed warning about the increased risk of hemorrhage, including severe and sometimes fatal hemorrhagic events.
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