Fruzaqla, new drug for metastatic colorectal cancer, expands Korean approval as a third-line treatment

The first new drug for metastatic colorectal cancer, Fruzaqla (fruquintinib), which selectively targets only vascular endothelial growth factor receptors (VEGFR)-1, 2, and 3, has just been approved for use starting from third-line treatment.

Takeda Pharmaceutical Korea announced on Wednesday that Fruzaqla received expanded approval from the Ministry of Food and Drug Safety (MFDS) the previous day for use as a third-line monotherapy for patients with metastatic colorectal cancer who have failed second-line treatment.

Colorectal cancer ranks as the second most common cancer in Korea. Due to factors like Westernized diets, its incidence and growth rate are increasing among younger populations, heightening the societal disease burden. Approximately half of colorectal cancer patients experience metastasis, with their five-year survival rate standing at only 20.6 percent. Survival rates decline further as the stage of treatment advances.

Particularly in the third-line or later anticancer treatment stages, the limited drug options available have placed a significant burden on patients. Colorectal cancer in Korea ranks third in disease burden as measured by DALY (Disability-Adjusted Life Years) after lung and stomach cancer, causing enormous costs not only in direct medical expenses but also in indirect costs like lost productivity.

Fruzaqla is an innovative new drug for metastatic colorectal cancer, the first to emerge in a decade according to U.S. Food and Drug Administration standards, usable regardless of genetic mutations or biomarker presence. Designated as the MFDS’s “Global Innovative products on Fast Track (GIFT)” program, it received its first approval in March this year as a treatment for fourth-line or later metastatic colorectal cancer. Within just six months, its indication was expanded to include third-line treatment.

Currently, Fruzacla is recommended by the U.S. National Comprehensive Cancer Network (NCCN) and the European Society for Medical Oncology (ESMO) for the treatment of patients with third-line or later metastatic colorectal cancer who have received prior therapy, at “Category 2A” and “I, A” levels, respectively.

Clinical trial results for Fruzaqla showed a median overall survival of 9.3 months in the Fruzaqla group, extending survival by 2.7 months compared to 6.6 months in the placebo group. The risk of death was reduced by 35 percent. The median progression-free survival was 3.7 months, more than doubling the 1.8 months in the placebo group. The risk of disease progression or death was reduced by 74 percent.

“Metastatic colorectal cancer has long been an area where new drugs struggle to achieve clinical improvement,” said Professor Oh Sang-cheul of the Department of Medical Oncology at Korea University Guro Hospital, who also chairs the Colorectal Cancer Subcommittee of the Korean Cancer Study Group. “Particularly from the third-line treatment stage onwards, the available treatment options are limited, leaving patients in a situation where they either abandon treatment or have no choice but to reuse previously administered drugs.”

Professor Oh continued, “Fruzaqla, with its novel mechanism that selectively targets only VEGFR-1,2,3, demonstrated a 2.7-month clinical improvement. This is a more significant result compared to other cancer types. Given the confirmed safety profile benefits, we expect it to present new possibilities for the survival of metastatic colorectal cancer patients in Korea.”