Ramucirumab

The approval was based on the results of the REGARD trial, a phase III, international, randomized, double-blind, placebo-controlled study, that evaluated the safety and efficacy of ramucirumab combinated with best supportive care versus placebo.

[11] In December 2014, the FDA approved ramucirumab in combination with docetaxel for treatment of metastatic non-small-cell lung carcinoma (NSCLC) with disease progression during or after first-line platinum-containing chemotherapy.

[12] In April 2015, ramucirumab was approved by FDA for the treatment of patients with metastatic colorectal cancer (mCRC) with disease progression on or after prior therapy with bevacizumab, oxaliplatin, and fluoropyrimidine.

[13] In May 2019, ramucirumab was approved by FDA as a single agent treatment for hepatocellular carcinoma (HCC) in patients who have an alpha fetoprotein (AFP) of > 400 ng/mL and have been previously treated with sorafenib.

In September 2013, the manufacturer Eli Lilly announced that its phase III study for ramucirumab failed to hit its primary endpoint on progression-free survival among women with metastatic breast cancer.

[19] Between 2016 and 2018, 26 hospitals in Italy conducted a multicentre, randomised, double-blind, placebo-controlled, phase II trial to evaluate the safety and effectiveness of the anti-VEGFR-2 antibody ramucirumab combined with gemcitabine in patients with pretreated  pleural mesothelioma.