FDA Approves Taiho Oncology’s 'Landscape Changing' Treatment for mCRC

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The US Food and Drug Administration (FDA) has approved a drug called Lonsurf (trifluridine/tipiracil) as a single agent or in combination with bevacizumab based on data from a pivotal clinical trial​. The results showed the treatment resulted in statistically significant and clinically meaningful improvements in overall survival for patients with mCRC 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.

Marwan Fakih is professor of medical oncology and therapeutics research at the City of Hope, Duarte, California, and lead US investigator for the phase 3 Sunlight trial that evaluated this combination.

He said: “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.”

The results from the trial​, which were published in the New England Journal of Medicine in May 2023, demonstrated that the combination of Lonsurf plus bevacizumab provided statistically significant and clinically meaningful improvements in overall survival (OS) and progression-free survival (PFS) for patients with mCRC following disease progression or intolerance on two prior chemotherapy regimens compared to Lonsurf alone.

This was the first phase 3 study against an active control in third-line mCRC that demonstrated statistically significant efficacy and safety.

Timothy Whitten, president and CEO at Taiho Technology Inc, said: “The treatment of advanced colorectal cancer has been a core focus of our work at Taiho Oncology since our inception and with good reason - approximately 22% of patients with colorectal cancer in the U.S. are diagnosed after the cancer has metastasized.

“The FDA approval of Lonsurf in combination with bevacizumab is another example of how we are continuing to advance care in this disease and provide new hope to patients and their families.”

On July 31, this year (2023), Servier, which conducted the trial with Taiho Oncology, received approval from the European Commission for Lonsurf in combination with bevacizumab for the treatment of adult patients with mCRC who have received two prior anti-cancer treatment regimens, including fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapies, anti-VEGF agents, and/or anti-EGFR agents. The Marketing Authorization covers the 27 countries of the European Union as well as Iceland, Northern Ireland, Liechtenstein, and Norway.

“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 programs,” said Fabio Benedetti, MD, global chief medical officer for oncology, Taiho Pharmaceutical Co., Ltd.

“And now we look forward to supporting healthcare professionals in the treatment of patients with mCRC who may become candidates for treatment with LONSURF in combination with bevacizumab.”

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