Eli Lilly seeking third Cyramza indication on colorectal results.
By Aine Slowey, Lead Analyst
23 September 2014
I am the Lead Analyst for cardiovascular and metabolic diseases at Datamonitor Healthcare. I have a DPhil in Organic Che...
Read full bio
Eli Lilly will pursue US FDA approval during the first half of 2015 for its VEGF receptor 2 antagonist Cyramza (ramucirumab) in the second-line treatment of colorectal cancer based on survival gains observed in the Phase III RAISE clinical trial.
Cyramza provided statistically significant improvements in overall and progression-free survival in RAISE for metastatic colorectal cancer patients who failed treatment with Roche/Genentech’s Avastin (bevacizumab), oxaliplatin and a fluropyrimidine. Colorectal cancer could be Cyramza’s third approved indication, following the expected submission of a biologic license application (BLA) in lung cancer later this year.
Datamonitor Healthcare’s pipeline research (click here to view the report) had predicted that Cyramza would need to demonstrate significant clinical activity in its Phase III trial in order to distinguish itself from other VEGF-targeted therapies in colorectal cancer. Datamonitor Healthcare has also recommended that Eli Lilly carefully monitor Cyramza’s pricing strategy to ensure that the drug remains competitive in this market, as inflated prices have previously limited uptake of VEGF-targeted drugs.
Sagient Research raised the likelihood of FDA approval for Cyramza in colorectal cancer by 8% to 75% in its 12 September BioMedTracker report on the RAISE results – that’s an 8% higher than average likelihood of approval for drugs in similar stages of development.
If you wish to read more about this particular update you can click here to read an article on our sister product, Scrip Intelligence.
Posted in Oncology.