The Food and Drug Administration (FDA) has approved a 10mg/mL solution for first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) harboring EGFR exon 19 deletions or exon 21 mutations. This solution is of ramucirumab injection combined with erlotinib. This combination is now the first and only FDA-approved anti-VEGFR/EGFR TKI combination therapy. This recent FDA approval makes ramucriumab to have six approvals to treat certain types of lung, stomach, liver and colorectal cancers.
This approval has been based on the efficacy and safety results from global, placebo-controlled phase III RELAY trial. The study randomized 449 patients receiving either rumacirumab-containing regimen or placebo-containing regimen. The combination demonstrated statistically significant and clinically meaningful improvement in median progression-free survival (PFS) by 7 months as compared to 19.4 months by erlotinib alone. This PFS benefit was observed across several lung cancer patient subgroups including those with EGFR mutations.
Ivy Elkins, confounder of EGFR Resisters said, “We’re encouraged by (ramucirumab’s) latest approval, which represents one step towards our goal of making EGFR-mutated non-small cell lung cancer in a manageable chronic disease.” “Each new treatment options gives hope to those living with this disease and provides oncologists with more options that may help slow the spread of this deadly cancer, which is an important goal for many patients,” he added.
Ramucirumab was previously approved for use in combination with docetaxel for treating patients with metastatic NSCLC who progressed while or following treatment with platinum-based chemotherapy. The label for ramucirumab includes warnings for impaired wound healing, arterial thromboembolic events, thyroid dysfunction, hemorrhage and gastrointestinal hemorrhage, worsening of pre-existing hepatic impairment etc.
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