FDA approves Taiho Oncology's pill for metastatic colorectal cancer
- Lonsurf is a 2-in-1 combo therapy that combines trifluridine with tipiracil hydrochloride.
- Approval is based on phase 3 data showing a 32% risk of death versus placebo (P<0.001).
- The FDA has qualified Lonsurf's approval with a warning about severe treatment-related myelosuppression (anemia, neutropenia, thrombocytopenia, and febrile neutropenia) and the need to keep tabls on white blood counts throughout treatment.
As the second-leading cause of cancer death (when combining both sexes) and the third most common type of cancer in the U.S., colorectal cancer is still considered an area where additional oncologic treatments are needed.
With Lonsurf, patients whose cancer is no longer responding to fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy have another oral treatment option. In a study, median overall survival was 7.1 months in Lonsurf-treated patients, compared with 5.1 months in placebo-treated patients.
Lonsurf is already approved in Japan and currently under regulatory review in Europe.
- Pharma Times FDA approves new advanced colorectal cancer pill