FDA Approves Ramucirumab for Treatment of Metastatic NSCLC

It is the third indication the drug has received in 2014

On 12 December, 2014 the USA Food and Drug Administration (FDA) expanded the approved use of ramucirumab (Cyramza) to treat patients with metastatic non-small-cell lung cancer (NSCLC). The drug is intended for patients whose tumour has progressed during or following treatment with platinum-based chemotherapy, and it is to be used in combination with docetaxel.

Ramucirumabis a fully human monoclonal antibody (IgG1) directed against the vascular endothelial growth factor receptor 2 (VEGFR2). By binding to VEGFR2, it works as a receptor antagonist blocking the binding of vascular endothelial growth factor (VEGF) to VEGFR2. VEGFR2 is known to mediate the majority of the downstream effects of VEGF in angiogenesis.

“Today’s approval is the third indication that Cyramza has received in 2014,” said Dr Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “The commitment to study Cyramza in a variety of malignancies provides important treatment options to patients.”

On 21 April, the FDA approved ramucirumab as a single agent to treat patients with advanced gastric cancer or gastroesophageal junction (GEJ) adenocarcinoma. On 5 November, the FDA expanded ramucirumab’s use to treat patients with advanced gastric or GEJ adenocarcinoma in its combination with paclitaxel.

The approval of ramucirumab plus docetaxel for metastatic NSCLC is based on a clinical study of 1,253 participants with previously treated and progressive NSCLC. Study participants were randomly assigned to receive ramucirumab plus docetaxel or a placebo plus docetaxel. Treatment was given until disease progression or development of intolerable side effects. The trial was designed with overall survival, as primary endpoint.

The results showed that half of the participants treated with ramucirumab plus docetaxel survived an average of 10.5 months from the start of treatment, compared to an average of 9.1 months from the start of treatment for half of the participants who received placebo plus docetaxel.

The most common side effects associated with ramucirumab plus docetaxel observed in the clinical study included neutropaenia, fatigue and stomatitis. Ramucirumab can cause severe bleeding, blood clots, elevation in blood pressure and may impair wound healing.

The FDA reviewed ramucirumab’s application for this new use under the agency’s priority review programme, which provides for an expedited review of drugs that are intended to treat a serious disease or condition and, if approved, would offer significant improvement compared to marketed products.

Ramucirumab (Cyramza) is marketed by Indianapolis-based Eli Lilly.

Video commentary by Prof. Lucio Crino on topline results from the phase III REVEL study with docetaxel/ramucirumab vs. docetaxel/placebo in second-line treatment of patients with NSCLC tumours of non-squamous and squamous histology, randomised 1:1, following disease progression after one prior platinum-based therapy.