The approval is intended for using Lonsurf either as a single agent or with bevacizumab in patients previously treated with oxaliplatin, fluoropyrimidine and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and if RAS wild-type [without mutations], with an anti-EGFR therapy.
Based on data from the Phase III SUNLIGHT study, the FDA granted approval for the combination of Lonsurf and bevacizumab.
This combination showed improvements in progression-free survival and overall survival in patients with mCRC after disease progression or who could not tolerate two previous chemotherapy regimens.
These results were compared to the outcomes using LONSURF alone.
“The FDA approval of Lonsurf in combination with bevacizumab is another example of how we are continuing to advance care in this disease and provide new hope to patients and their families.”