Taiho Oncology has received approval from the US Food and Drug Administration (FDA) for Lonsurf (trifluridine and tipiracil) to treat patients with metastatic colorectal cancer (mCRC).
Previously called as TAS-102, Lonsurf is approved for mCRC patients who have been previously treated with fluoropyrimidine, oxaliplatin and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and if RAS wild-type, an anti-EGFR therapy.
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Approval is based on results from the global Phase III Recourse trial in 800 patients who have been previously treated for mCRC.
The Recourse trial met the primary efficacy endpoint of statistically significant improvement in OS compared to placebo.
Dana Farber Cancer Institute Academic Affairs faculty vice-president and principal investigator of the Recourse trial Robert Mayer said: "Metastatic colorectal cancer cells often become resistant to previously effective treatment, underscoring the importance of identifying new therapeutic options for patients with the disease.
"In a pivotal clinical trial, Lonsurf demonstrated that it can extend overall survival, providing patients and their oncologists with a novel oral therapy."
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By GlobalDataData from the trial showed that Lonsurf reduced the risk of death by 32% when compared to placebo.
The company noted that the median OS was 7.1 months and 5.3 months for Lonsurf and placebo respectively.
Taiho Oncology president and chief executive officer Eric Benn said: "Patients with metastatic colorectal cancer, whose disease has progressed after treatment with standard therapies, have had limited therapeutic options to treat their disease.
"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."
In Japan, Lonsurf was approved in March 2014 for the treatment of unresectable advanced or recurrent colorectal cancer.
Image: Invasive adenocarcinoma, the most common type of colorectal cancer. Photo: courtesy of Nephron.
