Lilly’s Cyramza approved in EU for stomach cancer
The European Commission has granted marketing authorisation (MA) for Eli Lilly's ramucirumab (Cyramza) in stomach cancer, making it the first therapy approved for second-line advanced stomach and gastro-oesophageal junction (GOJ) cancer in the region.
The approval follows a similar ruling by the US Food and Drug Administration (FDA) in November, allowing Cyramza to be given with paclitaxel, and helps reinforce Lilly's position as a leader in oncology.
The FDA also gave the green light earlier this month for its use in non-small cell lung cancer (NSCLC) and Lilly hopes it will be approved early next year for metastatic colorectal cancer, based on phase III studies showing improved overall survival rates. It has been tipped as a top prospect for the company – predicted to generate sales of over $1.5 billion a year at its peak.
It is the first licensed therapy specifically indicated for adult patients with advanced gastric or GOJ adenocarcinoma, 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.
The approval is based on two international phase III studies, showing it extended overall survival time and delayed disease progression versus each study comparator.
"Unfortunately, most patients with gastric cancer face a poor prognosis. Around 80 per cent 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," said Prof David Ferry, global senior medical director at Lilly.
The phase III study programme involved 1,020 patients from 289 cancer centres and showed that ramucirumab, combined with paclitaxel, significantly extended overall survival time to 9.6 months compared with 7.4 months for placebo plus paclitaxel.
As a single agent, ramucirumab extended overall survival time to 5.2 months compared with 3.8 months for best supportive care.
"Today marks an important milestone for patients with this difficult-to-treat disease," said Dr Richard Gaynor, SVP of product development and medical affairs at Lilly Oncology. "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."
The EMA's Committee for Medicinal Products for Human Use (CHMP) has recommended a further seven drugs for MA this month, including Holoclar, Mysimba, Xadago, Xydalba, Quinsair, Tasermity and Clopidogrel ratiopharm, which brings the total for the year to over 80.
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