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FDA approves Cyramza for treatment of advanced gastric cancer
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The FDA today approved ramucirumab for use in combination with paclitaxel for the treatment of patients with advanced gastric or gastroesophageal junction adenocarcinoma.
Ramucirumab (Cyramza, Lilly) was approved in April as a single agent for the treatment of patients with advanced gastric or gastroesophageal junction adenocarcinoma whose disease had progressed on or after prior fluoropyrimidine- or platinum-containing chemotherapy.
Richard Gaynor
“This FDA approval of Cyramza represents another milestone for people battling this devastating and difficult-to-treat disease,” Richard Gaynor, MD, senior vice president, product development and medical affairs for Lilly Oncology, said in a press release. “Lilly is pleased to continue delivering on its commitment to provide new treatment options to people living with cancer and those who care for them.”
The FDA based its decision on results of the phase 3 RAINBOW trial, a multicenter, double blind, placebo-controlled study that included 665 patients with previously treated advanced or metastatic gastric or gastroesophageal junction adenocarcinoma.
Efficacy endpoints for the trial included the major efficacy outcome measure of OS and the supportive efficacy outcome measures of PFS and objective response rate.
Patients were randomly assigned to ramucirumab (8 mg/kg every 2 weeks) combined with paclitaxel (80 mg/m2 once a week for 3 weeks of every 28-day cycle; n=330) or matched placebo plus paclitaxel (n=335).
According to study results, patients in the ramucirumab plus paclitaxel group demonstrated a median OS of 9.6 months vs. patients in the placebo plus paclitaxel group who exhibited median OS of 7.4 months (HR=0.81; 95% CI, 0.68-0.96).
Researchers also reported that PFS also was significantly longer for patients receiving ramucirumab plus paclitaxel (HR=0.64; 95% CI, 0.54-0.75).
Common adverse events associated with ramucirumab plus paclitaxel included fatigue/asthenia, neutropenia, diarrhea and epistaxis, whereas serious adverse reactions with ramucirumab plus paclitaxel included neutropenia and febrile neutropenia.