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Welcome back to the D.I.S.C.O., FDA’s Drug Information Soundcast in Clinical Oncology, Burst Edition, brought to you by FDA’s Division of Drug Information in partnership with FDA’s Oncology Center of Excellence. Today we’ll provide a quick update on a recent FDA cancer drug approval.

On November 8, 2023, the FDA approved fruquintinib (brand name Fruzaqla) for adult patients with metastatic colorectal cancer who received prior fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if RAS wild-type and medically appropriate, an anti-EGFR therapy.

Efficacy was evaluated in FRESCO-2 and FRESCO. FRESCO-2, an international, multicenter, randomized, double-blind, placebo-controlled trial, evaluated 691 patients with metastatic colorectal cancer who had disease progression during or after prior fluoropyrimidine-, oxaliplatin-, irinotecan-based chemotherapy, an anti-VEGF biological therapy an anti-EGFR biological therapy if RAS wild type, and at least one of trifluridine/tipiracil or regorafenib. FRESCO, a multicenter, placebo-controlled trial conducted in China, evaluated 416 patients with metastatic colorectal cancer who had disease progression during or after prior fluoropyrimidine-, oxaliplatin, and irinotecan-based chemotherapy.

In both trials patients were randomly allocated 2:1 to either fruquintinib 5 mg orally once daily or placebo for the first 21 days of each 28-day cycle plus best supportive care. Patients received therapy until disease progression or unacceptable toxicity.

Overall survival was the major efficacy outcome in both trials. In FRESCO-2, median overall survival was 7.4 months for those treated with fruquintinib and 4.8 months in the placebo group. In FRESCO, median overall survival was 9.3 months and 6.6 months in the respective treatment arms.

The most common adverse reactions reported in more than 20% of patients were hypertension, palmar-plantar erythrodysesthesia, proteinuria, dysphonia, abdominal pain, diarrhea, and asthenia.

This review was conducted under Project Orbis, an initiative of the FDA Oncology Center of Excellence. Project Orbis provides a framework for concurrent submission and review of oncology drugs among international partners. The application reviews are ongoing at the other regulatory agencies.

Health care professionals should report serious adverse events to www.fda.gov/medwatch.

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