The first and only novel targeted therapy approved for mCRC, regardless of mutation status, in more than a decade1-4

FRUZAQLA™ (fruquintinib) is indicated for the treatment of adult patients with mCRC who have been previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if RAS wild-type and medically appropriate, an anti-EGFR therapy.1

EGFR=epidermal growth factor receptor; mCRC=metastatic colorectal cancer; RAS=rat sarcoma; VEGF=vascular endothelial growth factor.

Now approved an innovation in metastatic colorectal cancer (mCRC).

FRUZAQLA was proven effective for patients with previously* treated mCRC1

*FRUZAQLA is indicated for 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 and medically appropriate, an anti-EGFR therapy.

FRUZAQLA was studied in >1100 patients across 2 phase 3 clinical studies: FRESCO and FRESCO-2.1

STUDY DESIGN: FRESCO-2 was an international, multicenter, randomized, double-blind, placebo-controlled, phase 3 study in 691 patients with previously-treated mCRC.1

The primary endpoint was overall survival (OS).1

OS in patients with previously treated mCRC

Median overall survival (OS) with FRUZAQLA™ + BSC was 7.4 months compared to 4.8 months with placebo + BSC. There was a 34% reduction in risk of death with FRUZAQLA™ + BSC vs the placebo + BSC.

Over 2.5 months improvement in median OS was seen with FRUZAQLA1

  • FRUZAQLA more than doubled progression-free survival1,4
    • FRUZAQLA + BSC had a median PFS of 3.7 months (95% CI, 3.5-3.8) vs. placebo + BSC, which had a median PFS of 1.8 months (95% CI, 1.8-1.9) (HR=0.32; 95% CI, 0.27, 0.39; P<0.001)1,3
  • Disease-control rate was stable for more than half of patients taking FRUZAQLA + BSC
    • 56% disease control rate with FRUZAQLA + BSC vs 16% disease-control rate with placebo + BSC3,a

This study was not powered to show significance in disease control rate.

aDisease control was defined as proportion of patients with a best overall response of confirmed complete response, partial response, or stable disease for ≥7 weeks.

In FRESCO-2, the majority of ARs were manageable and predictable1,3

In FRESCO-2, the most common (≥10% of patients) adverse reactions observed following treatment with FRUZAQLA were:1

Common adverse reactions of FRUZAQLA™ include fatigue, hypertension, stomatitis, abdominal pain, diarrhea, hypothyroidism, palmarplantar erythrodysesthesia, proteinuria, dysphonia, musculoskeletal pain, and arthralgia.

bRepresents a composite of multiple related terms. 

Predictable refers to ARs consistent with inhibition of VEGF and VEGFR*

Low rate of discontinuations due to ARs: 20% with FRUZAQLA + BSC vs 21% for placebo + BSC

Serious adverse reactions occurred in 38% of patients treated with FRUZAQLA + BSC. Serious adverse reactions in ≥2% of patients treated with FRUZAQLA included hemorrhage (2.2%) and gastrointestinal perforation (2.0%)1

Fatal adverse reaction(s) occurred in 14 (3.1%) patients who received FRUZAQLA. Fatal adverse reactions occurring in ≥2 patients include pneumonia (n=3), sepsis/septic shock (n=2), and hepatic failure/encephalopathy (n=2).1

AR=adverse reaction; BSC=best supportive care; CI=confidence interval; HR=hazard ratio.

*Despite predictability, individual patient experiences may vary.

Convenient, once-daily oral dosing1

One pill once daily.
Simple once-daily treatment

The recommended dose of FRUZAQLA is 5 mg orally once daily for the first 21 days of each 28-day cycle1

Take with or without food.
With or without food

Capsules (available in 5 mg and 1 mg) should be swallowed whole1

About the same time each day

Take a missed dose if <12 hours have passed since the missed scheduled dose. Do not take 2 doses on the same day to make up for a missed dose1

Simple dose reductions can be implemented to help manage adverse reactions. The recommended starting dose is 5 mg orally once daily. The first dose reduction is 4 mg orally once daily. The second dose reduction is 3 mg orally once daily. Permanently discontinue FRUZAQLA in patients unable to tolerate 3 mg orally once daily.1

  • Continue treatment until disease progression or unacceptable toxicity1
  • Do not take an additional dose if vomiting occurs after taking FRUZAQLA, but continue with the next scheduled dose1
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Review the FRUZAQLA Prescribing Information.