'Fruzaqla' passes the Cancer Disease Review Committee

After obtaining designation as an orphan drug·GIFT, reimbursement process for this drug is currently proceedeing

Has proposed the possibility of bringing new improvements to VEGFR inhibition

Product photo of Fruzaqla

Interest is drawn to the health insurance reimbursement listing process for 'Fruzaqla,' a new treatment for colorectal cancer.

According to industry sources, Takeda Pharmaceuticals Korea's Fruzaqla (fruquintinib), a colorectal cancer treatment that selectively inhibits Vascular Endothelial Growth Factor Receptor (VEGFR) 1, 2, and 3, is currently under discussion at the subcommittee level. This drug passed the Cancer Disease Review Committee of the Health Insurance Review and Assessment Service (HIRA) last March.

​It is to be seen whether Fruzaqla will pass the Pharmaceutical Reimbursement Evaluation Committee, the final hurdle at the HIRA stage, this year to become a standard treatment option for colorectal cancer.

Approved in South Korea in March of last year, Fruzaqla is an innovative anti-cancer drug previously designated as both an Orphan Drug and the item for the Global Innovative products on Fast Track (GIFT) program.

The specific indication for this drug is: "The treatment of adult patients with metastatic colorectal cancer (mCRC) who have been previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if RAS wild-type, an anti-EGFR therapy."

Currently, Fruzaqla remains a non-reimbursed drug. Takeda submitted an application for reimbursement to the health authorities last year and is currently proceeding through the listing steps. It remains to be seen if Fruzaqla will successfully secure reimbursement to allow for seamless prescribing to patients.

The clinical utility of Fruzaqla was confirmed through the FRESCO and FRESCO-2 Phase 3 studies.

Results from these trials demonstrated that Fruzaqla extended the median overall survival (mOS) to 9.3 months in previously treated metastatic colorectal cancer patients, a 2.7-month increase compared to the placebo group. Furthermore, it reduced the risk of death by 35%.

In addition to its clinical efficacy, Fruzaqla is an oral medication taken once daily without complex dietary restrictions. This convenience is expected to have a positive impact on patients' quality of life alongside its therapeutic effects.

Professor Dong-hoe Koo of the Department of Oncology at Kangbuk Samsung Hospital stated, "Fruzaqla has high drug specificity because it does not target unnecessary receptors. This allows for efficient VEGFR inhibition and continuous drug exposure. Its potential for combination therapy with existing agents is also worth evaluating in future clinical settings."

Meanwhile, colorectal cancer refers to malignant tumors occurring in the colon and rectum, categorized into colon cancer or rectal cancer depending on the location. Metastatic colorectal cancer (mCRC) occurs when the tumor spreads beyond the primary site to invade other organs.

As of 2022, the incidence rate of colorectal cancer in South Korea was 61.1 per 100,000 people, ranking second to thyroid cancer. Notably, the incidence rate among the younger population aged 40 and under stands at 12.9 per 100,000, the highest in the world. It poses a serious public health situation.