Lonsurf – pro
On Sept. 22, 2016, the Food and Drug Administration (FDA) announced the approval of using Lonsurf, a combination of drugs manufactured by the Taiho Oncology Inc., to treat colorectal cancer tumors that no longer respond to other forms of therapy. The FDA provided a description of the international double-blind RECOURSE study on 800 patients with metastasized colon cancer, with some patients on Lonsurf and some on a placebo. The primary endpoint of the study was overall survival and the secondary endpoint was progression-free survival. Patients treated with Lonsurf lived an average of 7.1 months compared to 5.3 months for those treated with placebo. On average, the time to disease progression was two months for patients on Lonsurf compared to 1.7 months for patients receiving placebo.
Thus, the prolongation of survival obtained by this drug is around 1.8 months. Historically, OS prolongation of this kind was considered sufficient to approve drugs, such was the case with even a lesser overall survival gain to approve Tarceva and gemcitabine for pancreatic cancer.
LONSURF [Prescribing Information]. Princeton, NJ: Taiho Oncology, Inc.; 09/2015
Mayer RJ, Van Cutsem E, Falcone A, et al.; for the RECOURSE Study Group. Randomized trial of TAS‑102 for refractory metastatic colorectal cancer. N Engl J Med. 2015;372(20):1909‑1919.
Raedler LA. Lonsurf (Trifluridine plus Tipiracil): A New Oral Treatment Approved for Patients with Metastatic Colorectal Cancer. Am Health Drug Benefits. 2016;9(Spec Feature):97–100.