Takeda launches Fruzaqla in Korea for hard-to-treat colorectal cancer

Takeda Korea has launched Fruzaqla (fruquintinib), a once-daily oral treatment for metastatic colorectal cancer (mCRC), making it the first VEGFR-1, -2, and -3 selective inhibitor approved in the country.

Cleared by the Ministry of Food and Drug Safety (MFDS) in March under Korea’s Global Innovative Product on Fast Track (GIFT) system, Fruzaqla is indicated for patients who have failed at least three prior treatments, including fluoropyrimidine-, oxaliplatin- and irinotecan-based chemo, anti-VEGF or anti-EGFR agents, and either trifluridine/tipiracil or regorafenib.

The launch fills a major gap in Korea, where colorectal cancer ranks as the second most common cancer and where nearly 20 percent of patients are diagnosed at a metastatic stage.

Even among early-stage cases, more than half eventually progress. Five-year survival for metastatic CRC remains just 20.6 percent, Takeda Korea said in Monday's release.

“Despite its high incidence and aggressiveness, metastatic colorectal cancer has lacked effective treatment options beyond third-line therapy,” said Professor Oh Sang-cheul of Korea University Guro Hospital's Colorectal Cancer Center. “Fruzaqla offers a meaningful option for late-stage patients with limited choices, providing strong efficacy through its selective VEGFR inhibition while keeping toxicity manageable.”

Backed by data from the global phase 3 FRESCO-2 trial, Fruzaqla cut the risk of death by 34 percent versus placebo, extending median overall survival to 7.4 months from 4.8 months. Progression-free survival more than doubled, from 1.8 months to 3.7 months, and the disease control rate hit 56 percent compared to 16 percent in the control arm.

Adverse events were generally manageable. Grade 3 or higher hypertension occurred in 14 percent of patients, elevated liver enzymes in 8 percent, and hand-foot syndrome, a common side effect in mCRC, was limited to 6 percent.

The drug, which requires no dietary restrictions, is expected to ease the treatment burden for patients who have cycled through multiple regimens.

“Fruzaqla is a novel therapeutic option that addresses an unmet need across a broad range of mCRC patients, independent of biomarker status,” said Kim Mi-seung, head of Takeda Korea’s oncology business. “As part of our global strategy focused on high-burden diseases, we’ll continue expanding access for Korean patients and beyond.”

Fruzaqla is the 20th product designated under Korea’s GIFT system, which expedites review for innovative drugs targeting serious conditions. The Korean approval follows Fruzaqla’s U.S. FDA nod in 2023, based on the same pivotal data.