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The FDA for previously treated metastatic colorectal cancer, the agency announced on Wednesday.

Fruquintinib -- an oral selective inhibitor of all three VEGF receptor kinases -- is indicated for patients whose cancer has progressed on standard fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, a VEGF inhibitor, and an EGFR inhibitor when indicated for RAS wild-type tumors.

Two large phase III trials -- and FRESCO-2 -- supported the approval. In combination with best supportive care, the targeted agent demonstrated significantly improved overall survival (OS) and progression-free survival versus placebo.

"Patients with metastatic disease are often fragile and fatigued -- due to both their condition as well as the therapies they have been exposed to," Cathy Eng, MD, of Vanderbilt University Medical Center in Nashville, Tennessee, said in a from drugmaker Takeda. "An oral, chemotherapy-free option that offers a survival benefit despite treatment with prior therapies is a critical need for treating metastatic colorectal cancer."

"Colorectal cancer is a highly heterogeneous disease, making it difficult to bring advancements to patients whose cancer has metastasized. I look forward to being able to offer a new solution to appropriate patients," added Eng.

In the international FRESCO-2 trial, which included sites in the U.S., median OS improved from 4.8 months with placebo and best supportive care to 7.4 months with fruquintinib (HR 0.66, 95% CI 0.55-0.80, P<0.001). And in FRESCO, a study conducted exclusively in China, median OS values improved from 6.6 months to 9.3 months, respectively (HR 0.65, 95% CI 0.51-0.83, P<0.001).

Dosing for the oral drug is 5 mg once daily for the first 21 days of 28-day cycles, with or without food.

Common adverse events (≥20%) across the two trials included hypertension, hand-foot syndrome, proteinuria, dysphonia, abdominal pain, diarrhea, and asthenia.

Along with the risks for hypertension, hand-foot syndrome, and proteinuria, other warnings and precautions in the include hemorrhagic events, infections, gastrointestinal perforation, liver toxicity, posterior reversible encephalopathy syndrome, arterial thromboembolic events, impaired wound healing, allergic reactions to Yellow No. 5 and No. 6 food coloring, and embryo-fetal toxicity. Concomitant use with strong or moderate CYP3A inducers should be avoided.

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