Recently, the FDA approved the use of trifluridine-tipiracil tablets as a method of treatment for patients with metastatic colorectal cancer, who’ve already been through chemotherapy. The drug was initially granted a fast-track status after a phase 3 trial showed improved survival. This drug is intended to be a third line treatment option for patients whose cancer has progressed after treatment with standard therapies have failed, where there are otherwise limited options.
The fast-track process allows for faster development and review of new drugs developed to treat life-threatening conditions, as long as they have the potential to address currently unmet medical needs.
Taiho Oncology, Inc. will market the drug under the name Lonsurf. The drug was made available in September 2015.
The FDA says the trifluridine prevents cancer cell proliferation through interfering with the DNA synthesis process, and the tipiracil boosts exposure so there is no need to increase the cytotoxic medication’s dose.
Clinical studies showed that those who received the drug lived in median of 1.8 months longer than the patients who did not receive the product.
Doses of this combination products are based on the cytotoxic component – trifluridine – and are rounded to the nearest 5 mg dose. According to the product labeling, patients should receive 35 mg/m2 twice a day for days one through five and again on days eight through 12 of every 28 day treatment cycle. Doses should not exceed 80 mg. Doses should be taken within one hour of eating the morning and evening meals.
Therapy is allowed to continue until the cancer progresses or the toxic effects of the treatment are no longer acceptable.
At least 20% of patients who took this medication in the trial experienced: fatigue, decreased appetite, nausea, vomiting, diarrhea, abdominal pain, anemia, thrombocytopenia, and neutropenia.
The product labeling also includes instructions about how and when to start a treatment cycle, as well as how and when to reduce the dosage or to skip doses in the event a patient experiences severe adverse reactions.
The drug is manufactured in two strengths – 15 mg and 20 mg. The 15 mg tablet includes 6.14 mg of tipiracil, and the 20 mg tablet contains 8.19 mg. They will be packaged in 20, 40, and 60 count bottles. Any tablets that are not stored in their original bottle need to be discarded after 30 days.
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