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FDA approves Lonsurf for refractory metastatic colorectal cancer
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The FDA approved trifluridine and tipiracil for the treatment of patients with metastatic colorectal cancer, according to a press release from its manufacturer.
Trifluridine and tipiracil (Lonsurf, Taiho Oncology) is indicated for use in patients who underwent prior treatment with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF biological therapy and — for those with RAS wild-type tumors — an anti-epidermal growth factor receptor therapy.
“Patients with metastatic colorectal cancer, whose disease has progressed after treatment with standard therapies, have had limited therapeutic options to treat their disease,” Eric Benn, Taiho Oncology’s president and CEO, said in a press release. “Lonsurf helps address this unmet medical need by providing patients with a new therapeutic option that can help extend their overall survival. As the first FDA approval for Taiho Oncology, Lonsurf also represents a major milestone for our company.”
The FDA based its decision on results of the phase 3 RECOURSE trial, which included 800 patients with previously treated metastatic colorectal cancer.
Results showed trifluridine and tipiracil — formerly known as TAS-102 — significantly extended median OS compared with placebo (7.1 months vs. 5.3 months; HR = 0.68; 95% CI, 0.58-0.81).
The most common adverse drug reactions were asthenia/fatigue (52% for the study drug vs. 35% for placebo), nausea (48% vs. 24%), decreased appetite (39% vs. 29%), diarrhea (32% vs. 12%), vomiting (28% vs. 14%), abdominal pain (21% vs. 18%), pyrexia (19% vs. 14%), stomatitis (8% vs. 6%), dysgeusia (7% vs. 2%) and alopecia (7% vs. 1%).
Some patients treated with trifluridine and tipiracil experienced grade 3 to grade 4 neutropenia (38%), anemia (18%), thrombocytopenia (5%) and febrile neutropenia (3.8%). One patient (0.2%) died due to neutropenic infection.
“Metastatic colorectal cancer cells often become resistant to previously effective treatment, underscoring the importance of identifying new therapeutic options for patients with the disease,” Robert J. Mayer, MD, faculty vice president for academic affairs at Dana-Farber Cancer Institute, professor of medicine at Harvard Medical School and principal investigator of the RECOURSE study, said in a press release. “In a pivotal clinical trial, Lonsurf demonstrated that it can extend overall survival, providing patients and their oncologists with a novel oral therapy.”