Eli Lilly and Company has announced that the European Commission has granted marketing authorisation for ramucirumab (Cyramza®).
Ramucirumab is the first licensed therapy specifically indicated for adult patients with advanced gastric (stomach) or gastro-oesophageal junction adenocarcinoma (GOJ), following prior chemotherapy (fluoropyrimidine and platinum). Ramucirumab is approved in combination with paclitaxel chemotherapy and as a single agent in patients for whom treatment with paclitaxel is not appropriate. Ramucirumab’s approval is based on two international Phase III studies, showing it extended overall survival time and delayed disease progression versus each study comparator.1–3
“Unfortunately, most patients with gastric cancer face a poor prognosis. Around 80% are first diagnosed once their cancer has spread and become difficult to treat. Despite research efforts, there have been few advances in the last 30 years and inoperable gastric cancer remains a devastating disease. Ramucirumab provides a welcome new treatment option for these patients,” says Professor David Ferry, Global Senior Medical Director, Lilly Oncology and previous Professor of Medical Oncology, New Cross Hospital, Wolverhampton, UK
Ramucirumab’s Phase III study programme involved 1,020 patients from 289 cancer centres. Results from the RAINBOW study showed that ramucirumab, combined with paclitaxel, significantly extended overall survival time to 9.6 months compared with 7.4 months for placebo plus paclitaxel (hazard ratio [HR] 0.807 [95% CI 0.678–0.962]; p=0.017).2
As a single agent in the REGARD study, results showed ramucirumab extended overall survival time to 5.2 months compared with 3.8 months for best supportive care (HR 0.776, 95% CI 0.603–0.998; p=0.047).3 In both studies, ramucirumab was shown to delay disease progression and improve objective response rate ie tumour shrinkage.2,3
In the combination study, the most common adverse events of grade 3 or higher for ramucirmab plus paclitaxel versus placebo plus paclitaxel were neutropenia (41% vs 19%), leucopenia (17% vs 7%), hypertension (14% vs 2%), fatigue (12% vs 5%), anaemia (9% vs 10%) and abdominal pain (6% vs 3%). In the single agent study, adverse events were mostly similar between the ramucirumab and placebo groups, although rates of hypertension were higher (16% vs 8%).
‘Lilly is proud to have developed the first licensed therapy specifically indicated for second-line advanced stomach cancer and gastro-oesophageal junction adenocarcinoma. Today marks an important milestone for patients with this difficult-to-treat disease. Ramucirumab is an innovative therapy that specifically binds to and blocks vascular endothelial growth factor (VEGF) Receptor 2 – a key mediator of VEGF-induced angiogenesis, which feeds cancer growth. Ramucirumab’s development is testament to our commitment to support people living with cancer and those who care for them’ said Richard Gaynor, MD, Senior Vice President, Product Development and Medical Affairs for Lilly Oncology.
Ramucirumab was granted Orphan Drug Designation by the European Commission for treatment of gastric cancer in the EU. Orphan drug status is designated to medicines for the treatment of rare diseases, where available options are limited or where a medicine offers significant benefit over existing treatments.
- Cyramza® Summary of Product Characteristics (SPC)
- Wilke H et al. Ramucirumab plus paclitaxel versus placebo plus paclitaxel in patients with previously treated advanced gastric or gastro-oesophageal junction adenocarcinoma (RAINBOW): a double-blind, randomised phase 3 trial. Lancet Oncol 2014 Oct;15:1224-1235
- Fuchs C et al. Ramucirumab monotherapy for previously treated advanced gastric or gastro-oesophageal junction adenocarcinoma (REGARD): an international, randomised, multicentre, placebo-controlled, phase 3 trial. The Lancet 2014 Jan; 383:31-39