Plain Language Summary - An Analysis of the Safety of Futibatinib Treatment in People with Different Types of Cancer

Sep 21, 2026

Plain language summary describing a pooled analysis of futibatinib safety in patients across 33 cancer types. Researchers combined data from three phase 1 and 2 clinical trials involving more than 400 participants who received oral futibatinib tablets. The summary reports the frequency, timing, severity, and reversibility of key side effects, including hyperphosphatemia and stomatitis, and notes management considerations. Overall results indicate futibatinib is safe and tolerable, with few treatment-related discontinuations and no deaths.

LanguageEnglish

CategoryHealthcare

FormatPDF

Pages12

Reading Time30 min

AccessFree to download

Summary

What is this summary about?

What were the results?

What do the results mean?

Original article and context

Where can I find the original article on which this summary is based?

Key definitions used in the summary

Phase 1 clinical trial

Phase 2 clinical trial

Futibatinib

Pooled analysis

FGFRs and genes

Plain Language Summary of Publication Plain language summary: an analysis of the safety of futibatinib treatment in people with different types of cancer Funda Meric-Bernstam1, Antoine Hollebecque2, Junji Furuse3, Do-Youn Oh4,5, John A. Bridgewater⁶, Bailey Anderson⁷, Nanae Hangai⁷, Volker Wacheck7 & Lipika Goyal8,9 Full author affiliations can be found at the end of this article. First draft submitted: 13 August 2024; Accepted for publication: 7 October 2024 Where can I find the original article on which this summary is based? The original article discussed in this summary, called ‘Safety profile and adverse event management for futibatinib, an irreversible FGFR1–4 inhibitor: Pooled safety analysis of 469 patients,’ was published in Clinical Cancer Research in 2024. You can read the original article for free at: [https://aacrjournals.org/clincancerres/article/doi/10.1158/1078-0432.CCR-23-2646/734139/](https://aacrjournals.org/clincancerres/article/doi/10.1158/1078-0432.CCR-23-2646/734139/) Summary What is this summary about? Researchers combined information from three separate phase 1 and 2 clinical trials, including over 400 people who had one of 33 different cancer types and who all received futibatinib in their clinical trial. This type of study is called a pooled analysis. Futibatinib is taken orally (by mouth) as a tablet and works by reducing the activity of a group of proteins called fibroblast growth factor receptors (FGFRs) . FGFRs drive the growth of some cancers, especially cancer cells with changes in FGFR genes that make the proteins more active. Researchers wanted to look at how common some side effects were in people treated with futibatinib, how soon the side effects happened after taking futibatinib, and how they could be managed. Researchers also wanted to provide recommendations to other health care professionals on how to manage these side effects in people with cancer. How to say (download PDF and double click sound icon to play sound)... • Cholangiocarcinoma: koh-LAN-jee-oh-KAR-sih-NOH-muh • Fibroblast growth factor receptor: FY-broh-blast grothe FAK-ter reh-SEP-ter • Futibatinib: FUE-ti-BA-ti-nib • Hyperphosphatemia: HY-per-FOS-fat-EE-mee-uh • Kinase: KY-nays • Palmar-plantar erythrodysesthesia: PAL-mer-PLAN-ter eh-RITH-roh-DIS-es-THEE-zhuh • Stomatitis: STOH-muh-TY-tis What were the results? In this analysis, the researchers focused on side effects that they had seen in previously completed trials offutibatinib. Overall, futibatinib was safe and tolerable. Most people (82%) had a high phosphate level in their blood (hyperphosphatemia), 27% had nail disorders, 27% had liver side effects (changes in liver-related laboratory tests), 19% had a sore mouth (stomatitis), 13% had hand-foot syndrome (palmar-plantar erythrodysesthesia syndrome), 9% hada rash, 8% developed changes in the back of the eye (retinal disorders), and 4% of people developed cataracts. Most side effects were mild/moderate and reversible. The median time it took from starting treatment to experiencing a severe side effect ranged from 9 days (hyperphosphatemia) to 125 days (cataracts) . Some side effects tended to occur early, while others developed later. Only 2% of people stopped taking futibatinib due to treatment-related side effects, and futibatinib caused no deaths. What do the results mean? The side effects from taking futibatinib were manageable and similar in people with different types of cancer. To fully understand the safety offutibatinib, researchers will need to look at what side effects are reported in people taking futibatinib over a longer time in the real-world setting (outside of clinical trials) . 10. 1080/14796694 .2024.2414593 © 2024 The Authors Published by Informa UK Limited, trading as Taylor & Francis Group For reprints and re-use requests, please contact: [t&freprints@tandf.co. uk](t&freprints@tandf.co. uk) Future Oncol. (2025) 21(2), 13 9 –150 ISSN 1479-669

FAQs

What study design did the researchers use in this safety summary?

The researchers combined data from three separate phase 1 and 2 clinical trials into a pooled analysis. All participants received futibatinib in their original trials.

What were the most common side effects reported for futibatinib?

Hyperphosphatemia was most common (82%). Other frequently reported events included nail disorders (27%), liver-related laboratory changes (27%), stomatitis (19%), hand-foot syndrome (13%), and rash (9%).

What do the results suggest about the overall safety of futibatinib?

Side effects were generally manageable and similar across different cancer types. The summary also notes that most side effects were mild/moderate and reversible, with only 2% stopping due to treatment-related side effects and no deaths.

Sep 21, 2026

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