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Lonsurf Approved for Refractory Colorectal Cancer

Taiho Oncology’s oral product combines trifluridine and tipiracil

The FDA has approved trifluridine/tipiracil (Lonsurf, Taiho Oncology), formerly known as TAS-102, for the treatment of patients with metastatic colorectal cancer who have previously been treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and (if RAS wild-type) an anti-EGFR therapy.

“Metastatic colorectal cancer cells often become resistant to previously effective treatment, underscoring the importance of identifying new therapeutic options for patients with the disease,” said Robert J. Mayer, MD, Faculty Vice President for Academic Affairs at the Dana Farber Cancer Institute, Professor of Medicine at Harvard Medical School, and Principal Investigator of the RECOURSE study.

The FDA approval of Lonsurf is based on results from the global Phase III RECOURSE trial in 800 patients who had previously been treated for metastatic colorectal cancer (mCRC). The trial met the primary efficacy endpoint of a statistically significant improvement in overall survival (OS) compared with placebo (hazard ratio [HR], 0.68; 95% confidence interval [CI], 0.58–0.81; P  < 0.001). Lonsurf reduced the risk of death by 32% when compared with placebo. Median OS was 7.1 months (95% CI, 6.5–7.8) and 5.3 months (95% CI, 4.6–6.0) for Lonsurf and placebo, respectively.

Lonsurf caused severe and life-threatening myelosuppression (grade 3–4) consisting of anemia (18%), neutropenia (38%), thrombocytopenia (5%), and febrile neutropenia (3.8%). Complete blood counts should be obtained prior to and on day 15 of each cycle of Lonsurf and more frequently as clinically indicated. One patient (0.2%) died due to neutropenic infection.

The most common adverse drug reactions or laboratory abnormalities were anemia, neutropenia, asthenia/fatigue, nausea, thrombocytopenia, decreased appetite, diarrhea, vomiting, abdominal pain, and pyrexia. The most common adverse reactions leading to dose reduction were neutropenia, anemia, febrile neutropenia, fatigue, and diarrhea.

Lonsurf was approved in Japan in March 2014 and is indicated to treat unresectable advanced or recurrent colorectal cancer. Taiho Oncology is a subsidiary of Taiho Pharmaceutical (Japan).

Source: Taiho Oncology; September 22, 2015.

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