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FDA Approves New Oral Drug for Advanced Colorectal Cancer

doi: 10.1097/01.COT.0000473600.12803.56
FDA Updates
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The U.S. Food and Drug Administration has approved the oral drug Lonsurf (formerly TAS-102)—which is a combination of trifluridine and tipiracil—for the treatment of patients with metastatic colorectal cancer who are no longer responding to other therapies, including fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy; an anti-VEGF biological therapy; and if RAS wild-type, an anti-EGFR therapy.

“The past decade has brought a new understanding around colorectal cancer, in how we can both detect and treat this often devastating disease,” Richard Pazdur, MD, Director of the FDA's Office of Hematology and Oncology Products, said in a news release.

“But there are many patients who still need additional options, and this approval is a testament to the FDA's commitment to work with companies to develop new drugs in disease areas where unmet needs remain.”

Lonsurf, made by Taiho Oncology, Inc., received Fast Track Status for the indication last year (OT 11/25/14 issue).

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Safety & Efficacy

The drug's safety and efficacy were evaluated in the international, double-blind Phase III RECOURSE trial of 800 patients with previously treated metastatic colorectal cancer, randomized to receive Lonsurf plus best supportive care or placebo plus best supportive care (OT 8/10/15 issue). The patients receiving Lonsurf lived an average of 7.1 months with disease progressing on average after two months, while patients receiving the placebo lived an average of 5.3 months with disease progressing on average after 1.7 months.

The most common side effects for patients on Lonsurf were anemia, neutropenia or thrombocytopenia, physical weakness, fatigue, nausea, decreased appetite, diarrhea, vomiting, abdominal pain, and fever.

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Other Warnings

The FDA recommends that health care providers obtain complete blood counts prior to starting each treatment cycle of Lonsurf and monitor patients throughout treatment, as Lonsurf may cause myelosuppression. Health care providers are also encouraged to advise women of potential risks to developing fetuses when taking Lonsurf; and women taking Lonsurf should not breastfeed.

Lonsurf is manufactured by Taiho Oncology, Inc.

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Clinical Quick Facts: Lonsurf

Drug: Lonsurf (trifluridine and tipiracil)

Approved Indication: Treatment of patients with metastatic colorectal cancer who are no longer responding to other therapies, including fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy; an anti-VEGF biological therapy; and if RAS wild-type, an anti-EGFR therapy

Common Side Effects: Anemia, neutropenia or thrombocytopenia, physical weakness, fatigue, nausea, decreased appetite, diarrhea, vomiting, abdominal pain, and fever

Copyright © 2015 Wolters Kluwer Health, Inc. All rights reserved.
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