Lilly’s Cyramza has picked up its fourth US approval in just over a year, this time for the treatment of advanced colorectal cancer, significantly extending its patient reach.
The US Food and Drug Administration has OK’d the drug’s use in combination with FOLFIRI (irinotecan, folinic acid, and 5-fluorouracil) chemotherapy to treat metastatic colorectal cancer (mCRC) in patients whose disease has progressed despite therapy with Roche's Avastin (bevacizumab), oxaliplatin, and a fluoropyrimidine.
Approval came on the back of data from the RAISE trial, in which patients treated with the Cyramza (ramucirumab)/FOLFIRI regimen achieved a median overall survival of 13.3 months versus those given placebo/FOLFIRI who achieved 11.7 months, cutting the risk of patient death by 15%.
Cyramza works by preventing the formation of new blood vessels, thus starving the tumour of essential oxygen and nutrients. The drug is already approved in the US for gastric (both as single-agent and as combination therapies) and non-small cell lung cancer
Also of note, Cyramza’s labelling contains Boxed Warnings for: haemorrhage, including severe and sometimes fatal events; gastrointestinal (GI) perforation, a potentially fatal event; and impaired wound healing.