The US Food and Drug Administration (FDA) has approved Taiho Oncology’s Lonsurf (trifluridine and tipiracil) with bevacizumab for use in adults with heavily pre-treated metastatic colorectal cancer (mCRC).
The approval, which specifically applies to mCRC patients who were previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and if RAS wild-type, an anti-EGFR therapy, comes almost eight years after the regulator approved Lonsurf as a single-agent for the same indication.
The FDA’s latest decision was supported by positive results from the phase 3 SUNLIGHT trial, which demonstrated that the Lonsurf-based combination provided statistically significant and clinically meaningful improvements in overall survival and progression-free survival compared to Lonsurf as a monotherapy.
Compared with Lonsurf alone, the new combination reduced the risk of death by 39% in mCRC patients who had previously received two prior chemotherapy regimens.
The median progression-free survival for patients receiving the combination was 5.6 months, compared with 2.4 months in the Lonsurf arm, representing a 56% relative risk reduction of disease progression.
Lead US investigator for the study, Marwan Fakih, 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.”
He added: “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.”
Colorectal cancer is the third most commonly diagnosed cancer in the US, where approximately 153,020 new cases will be diagnosed this year.
Approximately 22% of US patients are diagnosed after their cancer has become metastatic, at which point treatment options are limited and prognosis is poor.
“The treatment of advanced colorectal cancer has been a core focus of our work at Taiho Oncology since our inception and with good reason,” said Timothy Whitten, the company’s president and chief executive officer. “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.”