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FDA expands approval of Cyramza to include aggressive NSCLC
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The FDA expanded the approved use of ramucirumab to include use in combination with docetaxel for second-line treatment of patients with metastatic non–small cell lung cancer who progressed on or after platinum-based chemotherapy, the drug’s manufacturer announced.
The indication stipulates that patients with epidermal growth factor receptor or anaplastic lymphoma kinase genomic tumor aberrations should have disease progression on an FDA-approved therapy for these aberrations prior to receiving ramucirumab (Cyramza, Lilly), a fully human monoclonal antibody.
“Lilly is determined to meet the challenge of delivering new treatments for people with difficult-to-treat cancers, such as non–small cell lung cancer,” Sue Mahony, PhD, senior vice president of Eli Lilly and president of Lilly Oncology, said in a press release. “We are pleased with this approval and excited for the therapeutic advantage that Cyramza in combination with docetaxel can bring to second-line, metastatic NSCLC patients.”
The FDA based its approval in part on results of the phase 3 REVEL trial. In that study, researchers compared ramucirumab plus docetaxel vs. docetaxel alone in patients with nonsquamous and squamous of NSCLC.
OS served as the primary endpoint. PFS and objective response rate served as secondary endpoints.
Results showed the combination of ramucirumab plus docetaxel was associated with longer median PFS (4.5 months vs. 3 months; HR=0.762; P<.0001) and longer median OS (10.5 months vs. 9.1 months; HR=0.857; 95% CI, 0.751-0.98). Researchers reported longer OS among patients with squamous and nonsquamous histology.
The combination also was associated with a statistically significant improvement in overall response rate. No unexpected adverse events were identified.
Ramucirumab contains a boxed warning regarding the increased risk for hemorrhage, including severe and sometimes fatal hemorrhagic events. The agent should be discontinued in patients who experience severe bleeding.
In April, the FDA previously approved ramucirumab as single-agent treatment for patients with advanced stomach cancer or gastroesophageal junction adenocarcinoma. In November, the FDA expanded the drug’s approved indication to include its use in combination with paclitaxel for treatment of patients with advanced gastric or gastroesophageal junction adenocarcinoma.