European regulators have approved Eli Lillys Cyramza (ramucirumab) giving patients with difficult-to-treat stomach cancers a new treatment option.
Specifically, the drug has won clearance to treat patients with advanced stomach or gastro-oesophageal junction adenocarcinoma, after prior chemotherapy with fluoropyrimidine and platinum, and it can be used in combination with paclitaxel or as a single agent.
Approval was based on clinical trials showing a potential survival benefit for patients; in the RAINBOW study, Cyramza plus paclitaxel extended overall survival time to 9.6 months compared with 7.4 months for placebo/paclitaxel, while
as a single agent in the REGARD study, Lilly’s drug extended overall survival to 5.2 months compared with 3.8 months for best supportive care.
“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,” noted David Ferry, Global Senior Medical Director, Lilly Oncology.
The drug has also been cleared in this setting for the US market, where it also recently received a green light for the treatment of metastatic non-small cell lung cancer in combination with docetaxel.