FDA approves Taiho’s Lonsurf for metastatic colorectal cancer treatment
Taiho Oncology and Taiho Pharmaceutical have announced that the US Food and Drug Administration (FDA) has approved Lonsurf (trifluridine/tipiracil) as a single agent or in combination with bevacizumab to treat adult patients with metastatic colorectal cancer (mCRC).
The drug’s approval provides another treatment option for mCRC patients who had previously been treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF biological therapy and, if RAS wild-type, an anti-EGFR therapy.
This approval is based on results from the phase 3 SUNLIGHT trial, which were published in the New England Journal of Medicine in May 2023. The trial showed that the combination of Lonsurf and bevacizumab provided a statistically significant and clinically meaningful improvement in overall survival (OS) and progression-free survival (PFS) for patients with mCRC.
Marwan Fakih, MD, professor of medical oncology and therapeutics research at City of Hope, California, US, and lead investigator on the phase 3 SUNLIGHT trial, commented: “The FDA approval of this combination provides patients with mCRC an important new treatment option, one that has been shown to extend life in addition to other benefits and which I believe will change the treatment landscape for this patient population. Notably, the use of Lonsurf plus bevacizumab in these patients did not result in an increase in potentially intolerable side effects that might limit the utility of this combination.”
Fabio Benedetti, MD, global chief medical officer for oncology at Taiho, added: “From Taiho Pharmaceutical’s initial discovery of Lonsurf to this latest regulatory milestone, we are appreciative of the investigators and patients who helped to contribute to our growing body of knowledge of this important therapeutic through their participation in our clinical development programmes. And now we look forward to supporting healthcare professionals in the treatment of patients with mCRC who may be candidates for treatment with Lonsurf in combination with bevacizumab.”
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