FDA Expedites Review of Lonsurf Regimens for Metastatic CRC


The FDA granted a priority review to Lonsurf with or without Avastin for the treatment of patients with pretreated metastatic colorectal cancer.

The Food and Drug Administration (FDA) granted a Priority Review for a supplemental new drug application for Lonsurf (trifluridine/tipiracil) alone or in combination with Avastin (bevacizumab) for the treatment of patients with pretreated metastatic colorectal cancer, according to Taiho Oncology, Lonsurf’s manufacturer.

Calendar image for Aug. 13. with caption: The FDA plans to make an approval decision by August 13

The FDA plans to make an approval decision regarding Lonsurf with or without Avastin for pretreated metastatic colorectal cancer on or before Aug. 13, 2023.

By granting a Priority Review, the FDA agrees to help speed up the assessment of a drug for potential approval. The agency declared that it plans to make its approval decision on this Lonsurf indication by Aug. 13, 2023.

“The poor prognosis for patients with previously treated, late-stage metastatic colorectal cancer has been an ongoing challenge in the oncology community, which has driven our pursuit of a potential new treatment option,” Dr. Volker Wacheck, vice president, clinical development, Taiho Oncology, Inc, said in a press release. “We believe the combination of (Lonsurf) plus (Avastin) may represent a significant advance in the treatment of refractory disease, and we look forward to working with the FDA as it considers this application.”

If approved, the Lonsurf regimen would be for patients with metastatic colorectal cancer who have been treated with an anti-VEGF biological therapy and, if their disease is RAS wildtype (meaning that there is no mutation in the RAS gene), an anti-EGFR therapy, too.

The Priority Review is based on findings from the phase 3 SUNLIGHT clinical trial, which involved 492 patients who were randomly assigned to receive either Lonsurf plus Avastin or Lonsurf alone.

Study findings showed that Lonsurf plus Avastin improved overall survival (time from treatment until death of any cause) as well as progression-free survival (time from treatment until disease gets worse) in this patient population, compared with those treated with Lonsurf alone.

Study findings, which were presented at the 2023 American Society of Clinical Oncology Gastrointestinal Cancers Symposium in January, found that the average overall survival was 10.8 months in the combination group and 7.5 months in the single-agent group, representing a 39% decrease in the risk of death.

Average progression-free survival was 5.6 months and 2.4 months in the Lonsurf/Avastin and Lonsurf alone groups, respectively. These data show a 56% relative risk reduction in disease progression, according to Taiho.

When presenting the study findings at the symposium earlier this year, Dr. Josep Tabernero, head of the department of medical oncology at Vall d’Hebron University Hospital, and director of the Vall d’Hebron Institute of Oncology in Barcelona, Spain, said that the Lonsurf-Avastin combination “represents a new standard of care for the treatment of patients with refractory metastatic (colorectal cancer) who had previously progressed after two lines of therapy.”

Additionally, in 2021, the National Comprehensive Cancer Network’s Drugs and Biologics Compendium for Colon Cancer and Rectal Cancer updated their recommendations to include a Category 2A recommendation (meaning that there is low-level evidence that the therapy can work and that using it would be appropriate) for the use of Lonsurf plus Avastin (or an Avastin biosimilar) for patients with metastatic colorectal cancer who have already tried all other available regimens.

According to Taiho’s press release, the two-drug combination had a manageable safety profile as well, with the most common side effect being neutropenia (a decrease in a type of white blood cell), which occurred in 43.1% of patients given Lonsurf and Avastin and 32.1% given Lonsurf alone. Another common side effect was anemia (decrease in red blood cells), which occurred in 6.1% and 11% of patients in the two-drug and single-agent groups, respectively.

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