FDA Approves Lonsurf for Metastatic Colorectal Cancer
For patients with metastatic CRC previously treated with chemotherapy, biological therapy
WEDNESDAY, Sept. 23, 2015 (HealthDay News) -- The combination pill Lonsurf (trifluridine and tipiracil) has been approved by the U.S. Food and Drug Administration to treat metastatic colorectal cancer in patients who aren't responding to other treatments, the agency said Tuesday in a news release.
Lonsurf was evaluated in clinical trials involving 800 patients with previously treated metastatic colorectal cancer. Those who took Lonsurf lived an average of more than seven months, compared to 5.3 months for those who took a placebo.
The drug's most common side effects include anemia, neutropenia, thrombocytopenia, weakness, fatigue, nausea, loss of appetite, diarrhea, abdominal pain, and fever.
Due to the potential for myelosuppression, doctors are urged to obtain complete blood counts prior to starting each treatment cycle of Lonsurf and monitor patients throughout treatment, the FDA said. Doctors also are advised to warn women of childbearing age of potential harm to developing fetuses. And women who use Lonsurf should not breastfeed, the agency warned.
Lonsurf is produced by Princeton, N.J.-based Taiho Oncology.