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

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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,† 

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

Disease 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

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aRepresents 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

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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
     

National Comprehensive Cancer Network® (NCCN®) recommends Fruquintinib (FRUZAQLA™) as a potential NCCN category 2A* treatment option for patients with previously treated mCRC5,6

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.

Potential treatment algorithms†‡

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*Category 2A is based upon lower-level evidence, meaning there is uniform NCCN consensus that the intervention is appropriate.
Other permutations and combinations are also recommended in NCCN guidelines. See NCCN Guidelines for full recommendation.
These examples are for BRAF and HER2 wild type, pMMR/MSS, and NTRK gene fusion negative disease, unless otherwise noted.
§If RAS mutant.
||If RAS wild type.

FOLFIRI=leucovorin, fluorouracil, and irinotecan; FOLFIRINOX=leucovorin, fluorouracil, oxaliplatin, and irinotecan; FOLFOX=leucovorin, fluorouracil, and oxaliplatin; HER2=human epidermal growth factor receptor 2; MSS=microsatellite stable; pMMR=proficient mismatch repair.

Adapted with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Colon Cancer V.1.2024. © 2024 National Comprehensive Cancer Network, Inc. All rights reserved. The NCCN Guidelines® and illustrations herein may not be reproduced in any form for any purpose without the express written permission of NCCN. To view the most recent and complete version of the NCCN Guidelines, go online to NCCN.org. The NCCN Guidelines are a work in progress that may be refined as often as new significant data becomes available.

Adapted with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Rectal Cancer V.1.2024. © 2024 National Comprehensive Cancer Network, Inc. All rights reserved. The NCCN Guidelines® and illustrations herein may not be reproduced in any form for any purpose without the express written permission of NCCN. To view the most recent and complete version of the NCCN Guidelines, go online to NCCN.org. The NCCN Guidelines are a work in progress that may be refined as often as new significant data becomes available. 

NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.
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Review the FRUZAQLA Prescribing Information.