FGFR1 antagonists(Fibroblast growth factor receptor 1 antagonists), FGFR2 antagonists(Fibroblast growth factor receptor 2 antagonists), FGFR3 antagonists(Fibroblast growth factor receptor 3 antagonists)

Therapeutic Areas

NeoplasmsDigestive System DisordersOther Diseases+ [4]

Active Indication

FGFR2 fusion or rearranged CholangiocarcinomaIntrahepatic CholangiocarcinomaBiliary Tract Neoplasms+ [15]

Inactive Indication

Advanced Malignant Solid NeoplasmAdvanced Urothelial CarcinomaCentral Nervous System Neoplasms+ [3]

Originator Organization

Taiho Pharmaceutical Co., Ltd.

Active Organization

Taiho Oncology, Inc.Merck Sharp & Dohme LLC

Taiho Pharmaceutical Co., Ltd.

Inactive Organization-

Drug Highest PhaseApproved

First Approval Date

United States (30 Sep 2022),

Intrahepatic Cholangiocarcinoma

RegulationAccelerated Approval (United States), Orphan Drug (United States), Orphan Drug (European Union), Orphan Drug (Australia), Conditional marketing approval (European Union), Priority Review (United States), Breakthrough Therapy (United States)

Structure/Sequence

Molecular FormulaC22H22N6O3

InChIKeyKEIPNCCJPRMIAX-HNNXBMFYSA-N

CAS Registry1448169-71-8

Clinical Trials associated with Futibatinib

NCT06722183

/ Not yet recruitingPhase 2IIT

FUTURE Platform Trial - A Phase II Platform Trial of Futibatinib in Combination With (Chemo)Immunotherapy in Colorectal Cancer and Other Solid Tumor Entities

The FUTURE trial is a prospective, multicentre, exploratory, open-label phase II platform trial. Its goal is to evaluate the efficacy, feasibility and safety of futibatinib combined with immunotherapeutic, targeted or chemotherapeutic agents in colorectal and other solid tumors and to additionally identify biomarkers that correlate with clinical outcome.

Start Date01 Mar 2025

Sponsor / Collaborator

Institut fr Klinische Krebsforschung IKF GmbH

NCT06263153

/ RecruitingPhase 2IIT

A Phase II Trial of Futibatinib in Combination with Durvalumab (MEDI4736) Administered to Cisplatin-Ineligible Patients with Muscle-Invasive Bladder Cancer Before Cystectomy

This phase II trial tests how well the combination of futibatinib and durvalumab given before cystectomy works in treating patients with muscle-invasive bladder cancer (MIBC) who are ineligible for cisplatin-based therapy. Cisplatin-based therapy is the standard of care for patients with MIBC. However, many patients cannot receive standard therapy due to poor renal function, peripheral neuropathy, poor functional status, or clinically significant heart failure. Futibatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Durvalumab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. Radical cystectomy is a surgery to remove all of the bladder as well as nearby tissues and organs. Giving futibatinib in combination with durvalumab before surgery may be an effective treatment option for patients with MIBC who are ineligible for cisplatin-based therapy.

Start Date30 Dec 2024

Sponsor / Collaborator

Ohio State University Comprehensive Cancer Center

[+1]

CTIS2024-512217-40-00

/ RecruitingPhase 2/3

An Open-label, Rollover Study of Futibatinib in Patients Previously Enrolled in an Antecedent Futibatinib Study - TAS-120-404

Start Date21 Oct 2024

Sponsor / Collaborator

Taiho Oncology, Inc.

100 Clinical Results associated with Futibatinib

100 Translational Medicine associated with Futibatinib

100 Patents (Medical) associated with Futibatinib

141

Literatures (Medical) associated with Futibatinib

01 Mar 2025·EUROPEAN JOURNAL OF CANCER

Phase 2 study of futibatinib in patients with gastric or gastroesophageal junction cancer harboring FGFR2 amplifications

Article

Author: Honda, Kazunori ; Barthélémy, Philippe ; Hirano, Hidekazu ; Park, Joon Oh ; Ajani, Jaffer ; Rha, Sun Young ; Doi, Toshihiko ; Shitara, Kohei ; Kremer, Jill ; Satoh, Taroh ; Liu, Mei ; Hangai, Nanae ; Nogova, Lucia ; Ryu, Min-Hee ; Mina, Mark ; Lee, Keun-Wook

BACKGROUND AND AIMS:

Aberrant fibroblast growth factor receptor (FGFR)-driven signaling, predominantly arising from FGFR2 amplification, plays a key role in gastric cancer pathogenesis. This open-label, phase 2 study evaluated the efficacy and safety of futibatinib, an irreversible FGFR1-4 inhibitor, in patients with gastric or gastroesophageal junction (GEJ) cancer harboring FGFR2 amplifications.

METHODS:

Patients were treated with futibatinib 20 mg orally once daily in a 28-day cycle. The primary endpoint was objective response rate (ORR) per independent central review. Secondary endpoints included progression-free survival (PFS), overall survival (OS), and safety.

RESULTS:

Among 28 treated patients, the ORR per independent central review was 17.9 %, comprising five patients with a partial response (median duration of response, 3.9 months), and an additional nine patients with stable disease for a disease control rate of 50.0 %. Median PFS per independent central review and median OS were 2.9 and 5.9 months, respectively. The most common treatment-related adverse events (any grade) were hyperphosphatemia (89.3 %), decreased appetite (32.1 %), and increased aspartate aminotransferase (21.4 %). Only one (3.6 %) patient discontinued study treatment due to an adverse event. Futibatinib demonstrated modest antitumor activity with a safety profile consistent with previous reports in patients with gastric or GEJ cancer harboring FGFR2 amplifications, potentially warranting further investigation.

14 Jan 2025·Future Oncology

Plain language summary: an analysis of the safety of futibatinib treatment in people with different types of cancer

Article

Author: Oh, Do-Youn ; Hangai, Nanae ; Bridgewater, John A. ; Furuse, Junji ; Goyal, Lipika ; Anderson, Bailey ; Hollebecque, Antoine ; Wacheck, Volker ; Meric-Bernstam, Funda

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.

WHAT WERE THE RESULTS?:

In this analysis, the researchers focused on side effects that they had seen in previously completed trials of futibatinib. 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% had a 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 of futibatinib, 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).

01 Dec 2024·EXPERT OPINION ON INVESTIGATIONAL DRUGS

Fibroblast growth factor therapies in biliary tract cancers: current and future state

Review

Author: Siripoon, Teerada ; Jin, Zhaohui ; Mahipal, Amit ; O’Donnell, Conor

INTRODUCTION:

Cholangiocarcinoma is the rare and aggressive tumor with poor prognosis and limited therapeutic options. Recently, there have been promising developments in molecular targeted therapies for patients following the progression of first-line chemotherapy and immunotherapy combinations. Dysregulation of fibroblast Growth Factor Receptor (FGFR) signaling is significantly associated with tumorigenesis of intrahepatic cholangiocarcinoma and has been identified as a targetable alteration. This was possible through the discovery of crucial insights into the biochemical mechanisms and pathophysiology of the FGFR pathway.

AREAS COVERED:

This review summarizes the current state of FGFR targeted therapies, mechanisms of resistance, and future directions for FGFR-targeted therapies in patients with cholangiocarcinoma.

EXPERT OPINION:

Currently, pemigatinib and futibatinib are FDA approved FGFR-targeted therapies that have demonstrated remarkable responses. However, there is still a significant proportion of patients whose disease remains intrinsically resistant to treatment and most patients eventually develop secondary resistance after an initial response. Additionally, unique side effects of FGFR inhibitors may limit their efficacy in clinical practice and can have detrimental effects on quality of life. Several novel FGFR inhibitors are currently being investigated to overcome resistance mechanisms and reduce toxicities.

News (Medical) associated with Futibatinib

17 Mar 2025

·www.fiercebiotech.com

Otsuka\'s Taiho pays $400M for Swiss partner to \'turbocharge\' 3 ADCs to clinic

Taiho Pharmaceutical\'s \"significant cancer expertise will support us in turbocharging the clinical development of our potent ADC candidates in hematological and solid tumors,” Araris Biotech\'s CEO said.\n Otsuka’s Taiho Pharmaceutical is paying $400 million upfront to acquire Switzerland’s Araris Biotech and its antibody-drug conjugate (ADC) linker platform.The two companies have been working together since November 2023, when Araris agreed to use its AraLinQ platform to develop ADCs aimed at Taiho’s targets of choice. Taiho presumably liked what it saw, as the biotech has now decided to go all-in and buy Araris.The deal will see Taiho hand over $400 million, with Araris’ shareholders potentially in line for a further $740 million in milestone payments, according to a March 17 release.Araris has its origins in Switzerland’s Paul-Scherrer-Institute, before spinning off in 2019. The biotech is focused on designing ADCs that have greater linker solubility, with three preclinical therapies aimed at hematological and solid tumors expected to enter human trials over the course of 2025 and 2026.Araris touts its linker tech as having three benefits over its competitors. Firstly, the attachment site on a specific amino acid within the antibody IgG-Fc framework means the antibody maintains almost the same performance when part of the ADC. Meanwhile, the strong peptide bond connecting the linker antibody to the therapy’s payload results in “exceptional stability in the blood stream and therefore, avoidance of healthy tissue damage,” according to the release. This bond then breaks easily inside a cancer cell.“Araris’ unique ADC technology represents a quantum leap for the ADC field, potentially offering precise payload delivery of multiple mechanisms of action simultaneously to the tumor, with less toxicity,” CEO and co-founder Dragan Grabulovski said. “We are proud to combine with Taiho, our partner since November 2023, whose significant cancer expertise will support us in turbo-charging the clinical development of our potent ADC candidates in hematological and solid tumors.”Taiho is a subsidiary of Japan’s Otsuka and markets a wide range of anticancer drugs in the country. In the U.S., the subsidiary has three FDA-approved products: the colorectal treatment Lonsurf, the bile duct cancer med Lytgobi and the myelodysplastic syndromes treatment Inqovi.Using Araris’ ADC drug tech alongside Taiho’s own small-molecule drug discovery platform Cysteinomix will allow Taiho to “further expand its ongoing development portfolio in the field of oncology,” according to this morning’s release.ADCs have been one of the hottest spaces for dealmaking in recent years, with the likes of AstraZeneca, Roche, Merck & Co. and Ipsen all posting billion-dollar-plus biobucks pacts.

$Otsuka\'s Taiho pays $400M for Swiss partner to \'turbocharge\' 3 ADCs to clinic$

ADCDrug ApprovalAcquisition

17 Mar 2025

·www.biopharmadive.com

Taiho buys Swiss biotech and its ADC tech for $400M

Japan-based Taiho Pharmaceuticals on Monday said it will acquire Switzerlands Araris Biotech and its antibody-drug conjugate technology for $400 million upfront.The two companies have worked together since 2023, when they agreed to use Araris technology to explore and develop new drug candidates aimed at targets chosen by Taiho. The deal announced Monday, which they expect to close in the first half of this year, could hand Araris up to $740 million more if certain milestones are met.Antibody-drug conjugates, or ADCs, pair tumor-killing toxins with a targeting molecule via a linker. Improvements in this linking technology have helped buoy the field, yielding new treatments and sparking greater investment. Many large pharmaceutical companies, among them AstraZeneca, Pfizer and Merck & Co, have inked multibillion-dollar deals to pad their pipelines with ADC prospects. AstraZeneca, together with its partner Daiichi Sankyo, have arguably had the most success recently with their ADC drugs Enhertu and Datroway.Spun off from the Paul Scherrer Institute six years ago, Araris was funded by 4BIO Capital in 2020 and again in 2022. The biotech touts its AraLinQ technology, which it claims can provide more stable and more potent ADCs. It is developing three candidates for blood and solid tumors, and expects to advance these prospects into clinical testing this year and next.Araris unique ADC technology represents a quantum leap for the ADC field, potentially offering precise payload delivery of multiple mechanisms of action simultaneously to the tumor, with less toxicity, Dragan Grabulovski, CEO and co-founder of Araris, said in a statement.Taiho, a subsidiary of Japans Otsuka, sells several cancer drugs in the U.S: Lytgobi for bile duct cancer, Lonsurf for colorectal cancer and the myelodysplastic syndromes treatment Inqovi. It also markets other anticancer medicines in Japan. '

ADC

10 Mar 2025

·www.prnewswire.com

BAVENCIO Continues to Strengthen Its Position in the Immuno-Oncology Landscape | DelveInsight

With the rising adoption of checkpoint inhibitors and combination therapies, BAVENCIO's market growth is driven by expanding indications and strategic partnerships. However, competition from KEYTRUDA and TECENTRIQ poses challenges, making differentiation through combination strategies key to its success. LAS VEGAS, March 10, 2025 /PRNewswire/ -- DelveInsight's " BAVENCIO Market Size, Forecast, and Market Insight Report" highlights the details around BAVENCIO, a human IgG1 lambda monoclonal antibody that targets programmed death-ligand 1 (PD-L1). The report provides product descriptions, patent details, and competitor products (marketed and emerging therapies) of BAVENCIO. The report also highlights the historical and forecasted sales from 2020 to 2034 segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan]. Pfizer/Merck/EMD Sereno's BAVENCIO (avelumab) Overview BAVENCIO is a human antibody targeting programmed death ligand-1 (PD-L1). Preclinical studies have demonstrated its ability to activate both adaptive and innate immune responses. By inhibiting the interaction between PD-L1 and PD-1 receptors, BAVENCIO helps restore T cell-mediated antitumor immunity in preclinical models. In November 2014, Merck KGaA, Darmstadt, Germany, and Pfizer formed a strategic partnership to jointly develop and commercialize BAVENCIO. In the U.S., BAVENCIO is approved for the maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma that has not progressed after first-line platinum-based chemotherapy. It is also indicated for patients with locally advanced or metastatic UC who experience disease progression during or after platinum-based chemotherapy or within 12 months of neoadjuvant or adjuvant platinum-based treatment. Additionally, BAVENCIO in combination with axitinib is approved in the U.S. for the first-line treatment of patients with advanced renal cell carcinoma. The FDA has also granted accelerated approval for BAVENCIO in the treatment of adults and pediatric patients (12 years and older) with metastatic Merkel cell carcinoma, based on tumor response rate and duration of response. Continued approval may depend on further clinical trials confirming its benefits. Currently, BAVENCIO is approved in 50 countries for at least one indication. Learn more about BAVENCIO projected market size for merkel cell carcinoma, urothelial carcinoma, and renal cell carcinoma @ BAVENCIO Market Potential Urothelial carcinoma is the most common cancer of the urinary system, arising from urothelial cells and primarily affecting individuals over the age of 50. It is more prevalent in males, with an incidence rate two to three times higher than in females. According to DelveInsight's analysis, approximately 41 million new cases of urothelial carcinoma were reported across the 7MM in 2023. The standard treatment primarily involves chemotherapy, particularly cisplatin-based regimens. For patients who do not respond to initial systemic therapy, immunotherapy—using agents such as atezolizumab and pembrolizumab—serves as a secondary option. In some cases, surgical interventions like nephroureterectomy are also performed. Approved treatment options for urothelial carcinoma include OPDIVO (nivolumab), PADCEV (enfortumab vedotin-ejfv), KEYTRUDA (pembrolizumab), and BAVENCIO (avelumab), among others. The urothelial carcinoma treatment market is projected to experience substantial growth, rising from USD 900 million in 2023 at a notable CAGR through 2034, driven by the introduction of innovative therapies currently in clinical trials. However, challenges such as treatment complications in elderly patients and dependence on blood transfusions may pose barriers to market expansion. Dive deep into an in-depth assessment of the Urothelial Carcinoma Market Merkel cell carcinoma is a rare and aggressive neuroendocrine skin cancer that originates from Merkel cells—specialized mechanoreceptors located at the dermo-epidermal junction responsible for touch sensation. According to DelveInsight's estimates, approximately 9,000 new cases of MCC were reported in the 7MM in 2023, with the United States accounting for 37% of these cases. Several approved treatments for MCC are currently available, primarily focusing on immune modulation. Notable therapies include BAVENCIO, a monoclonal antibody developed by Merck KGaA; KEYTRUDA (pembrolizumab), a PD-1 inhibitor from Merck; and ZYNYZ (retifanlimab-dlwr), a PD-1 inhibitor co-developed by Incyte Corporation and MacroGenics. DelveInsight's analysis estimates that the MCC treatment market in the 7MM was valued at approximately USD 411 million in 2023. Over the forecast period from 2024 to 2034, this market is expected to grow at a CAGR of 8.7%, driven by the introduction of innovative therapies. Discover more about the Merkel cell carcinoma market in detail @ Merkel Cell Carcinoma Market Report Renal cell carcinoma is the most prevalent form of kidney cancer, comprising approximately 90% of all cases. It ranks among the ten most common cancers worldwide. The prognosis for advanced RCC remains poor, with a five-year survival rate of around 11-12%. Research indicates that RCC accounts for the vast majority of kidney cancer cases. Over the past decade, the treatment landscape for advanced RCC has evolved significantly, driven by the introduction of novel therapies and advancements in surgical and ablative techniques. Treatment approaches have become increasingly personalized, with prognostic groups established to tailor interventions based on disease severity. For patients in good health with isolated metastases, surgical excision, radiotherapy, or ablative therapy may be recommended to postpone systemic treatment. Meanwhile, those ineligible for surgical removal may benefit from alternatives such as cryoablation, thermal ablation, or stereotactic ablative body radiation therapy. Additionally, targeted treatments like tyrosine kinase inhibitors (TKIs) and anti-VEGF antibodies have become essential in both first- and second-line therapy, offering effective management options for advanced RCC. The market outlook for advanced RCC appears promising, driven by ongoing innovations and the expansion of therapeutic options. As investigational treatments advance through clinical trials, they have the potential to significantly improve patient outcomes and address existing gaps in care. The competitive landscape is rapidly evolving, with developments in targeted therapies, immunotherapies, and combination treatments aiming to enhance survival rates and quality of life for patients with advanced RCC. For more insights on the evolving landscape of renal cell carcinoma, visit @ Advanced Renal Cell Carcinoma Market Emerging Competitors of BAVENCIO The urothelial carcinoma pipeline is highly dynamic, with promising new therapies in development, including IMFINZI + IMJUDO + SoC (AstraZeneca), Disitamab vedotin (Pfizer), Vactosertib + IMFINZI (MedPacto), TYRA-300 (Tyra Biosciences), LYTGOBI + KEYTRUDA (Taiho Oncology), UGN-104 (UroGen Pharma), and others. In the Merkel cell carcinoma space, the potential emerging competitors of BAVENCIO include IFx-2.0 (TuHURA Biosciences), NIDLEGY (L19-IL2/L19-TNF) (Philogen), ITI 3000 (Immunomic Therapeutics), PH 762 (Phio Pharmaceuticals/AgonOx), KT 253 (Kymera Therapeutics), MCLA 145 (Merus N.V.), and others. Key companies such as Exelixis/Bristol-Myers Squibb (Zanzalintinib (XL092) + Nivolumab), AstraZeneca/ HUTCHMED (Savolitinib + Durvalumab), Corvus Pharmaceuticals (Ciforadenant (CPI-444)), Xynomic Pharmaceuticals (Abexinostat), NiKang Therapeutics (NKT2152), and others are involved in developing drugs for advanced RCC. To know more about the number of competing drugs in development, visit @ BAVENCIO Market Positioning Compared to Other Drugs Key Milestones of BAVENCIO In January 2021, EMD Serono and Pfizer Inc. announced that the European Commission (EC) approved BAVENCIO as a monotherapy for first-line maintenance in adult patients with locally advanced or metastatic urothelial carcinoma who have remained progression-free after undergoing platinum-based chemotherapy. In December 2020, EMD Serono and Pfizer Inc. announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending the approval of BAVENCIO as a monotherapy for first-line maintenance in adult patients with locally advanced or metastatic urothelial carcinoma who have remained progression-free after undergoing platinum-based chemotherapy. In June 2020, EMD Serono and Pfizer Inc. announced that the FDA has approved the supplemental Biologics License Application (sBLA) for BAVENCIO as a maintenance treatment for patients with locally advanced or metastatic urothelial carcinoma whose disease has not progressed following first-line platinum-based chemotherapy. In June 2020, Merck KGaA and Pfizer Inc. announced that the European Medicines Agency (EMA) had accepted for review the Type II variation application for BAVENCIO as a first-line maintenance treatment for patients with locally advanced or metastatic urothelial carcinoma. In April 2020, EMD Serono and Pfizer Inc. finalized the submission of a supplemental Biologics License Application (sBLA) to the FDA for BAVENCIO as a first-line maintenance therapy for patients with locally advanced or metastatic urothelial carcinoma. In October 2019, Merck KGaA and Pfizer Inc. announced that the European Commission (EC) has granted approval for BAVENCIO in combination with axitinib as a first-line treatment for adults with advanced renal cell carcinoma (RCC). In May 2019, Merck KGaA and Pfizer Inc. announced that the FDA granted approval for BAVENCIO in combination with INLYTA as a first-line treatment for patients with advanced renal cell carcinoma (RCC). In December 2017, Merck KGaA and Pfizer Inc. announced that the FDA had awarded Breakthrough Therapy Designation to avelumab in combination with INLYTA (axitinib) for newly diagnosed patients with advanced renal cell carcinoma (RCC). In September 2017, Merck KGaA and Pfizer Inc. announced that the European Commission (EC) has approved BAVENCIO as a standalone treatment for adult patients with metastatic Merkel cell carcinoma (mMCC), a rare and aggressive form of skin cancer. In September 2017, Merck KGaA and Pfizer Inc. announced that Japan's Ministry of Health, Labour and Welfare (MHLW) has approved BAVENCIO as the first and only treatment for curatively unresectable Merkel cell carcinoma (MCC), a rare and aggressive cancer, in Japan. In May 2017, EMD Serono and Pfizer Inc. announced that the FDA approved BAVENCIO Injection to treat patients with locally advanced or metastatic urothelial carcinoma whose disease has progressed during or after platinum-based chemotherapy or within 12 months of receiving neoadjuvant or adjuvant platinum-based treatment. In March 2017, EMD Serono and Pfizer Inc. announced that the FDA has approved BAVENCIO Injection 20 mg/mL, an intravenous treatment for adults and pediatric patients aged 12 and older with metastatic Merkel cell carcinoma (mMCC). In November 2014, Merck KGaA, Darmstadt, Germany, and Pfizer formed a strategic partnership to jointly develop and market BAVENCIO. Discover how BAVENCIO is shaping the merkel cell carcinoma, urothelial carcinoma, and renal cell carcinoma treatment landscape @ BAVENCIO Injection BAVENCIO Market Dynamics BAVENCIO, co-developed by Merck KGaA and Pfizer, is an anti-PD-L1 checkpoint inhibitor primarily approved for urothelial carcinoma and Merkel cell carcinoma. Its key differentiation lies in its first-in-class approval for maintenance therapy in locally advanced or metastatic urothelial carcinoma, setting it apart from competitors like KEYTRUDA (pembrolizumab) and TECENTRIQ (atezolizumab). However, in the broader immuno-oncology (IO) landscape, BAVENCIO faces stiff competition from other PD-1/PD-L1 inhibitors that dominate indications in lung, renal, and other cancers. BAVENCIO's market uptake has been driven by its unique approval in the urothelial carcinoma maintenance setting, where it demonstrated a significant survival benefit. The drug has gained traction in major markets like the U.S., Europe, and Japan, benefiting from increased awareness and inclusion in treatment guidelines. However, its adoption has been tempered by physician familiarity with established IO therapies and payer considerations around cost-effectiveness, especially in competitive oncology segments. One of BAVENCIO's primary challenges is its limited label expansion compared to blockbuster PD-1 inhibitors like OPDIVO (nivolumab) and KEYTRUDA. While its urothelial carcinoma approval has a strong foothold, its lack of widespread use in high-incidence cancers like NSCLC constrains its market potential. Nonetheless, ongoing clinical trials exploring novel combination strategies with other immunotherapies and targeted agents could enhance its market positioning. Additionally, emerging markets and label expansions offer opportunities for future growth. The future of BAVENCIO will largely depend on its ability to secure new indications and differentiate itself in the crowded IO space. With increasing competition and biosimilar threats on the horizon, strategic partnerships, real-world evidence generation, and market access strategies will be crucial in sustaining its commercial success. Dive deeper to get more insight into BAVENCIO's strengths & weaknesses relative to competitors @ BAVENCIO Market Drug Report Table of Contents Related Reports Urothelial Carcinoma Market Urothelial Carcinoma Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key urothelial carcinoma companies including Pfizer, Merck, Eisai Inc, AstraZeneca, Seagen Inc, Bayer, Incyte Corporation, Acerta Pharma BV, among others. Urothelial Carcinoma Pipeline Urothelial Carcinoma Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key urothelial carcinoma companies, including MedPacto, AstraZeneca, Helsinn, QED Therapeutics, Inovio Pharmaceuticals, Abbisko Therapeutics, Bayer, 4D pharma plc, RemeGen, Infinity Pharmaceuticals, Kyowa Kirin, Inc., Ikena Oncology, Vyriad, Seagen, RemeGen, Pfizer, Incyte Corporation, Prestige BioPharma, TARIS Biomedical, Janssen Research and Development, among others. Merkel Cell Carcinoma Market Merkel Cell Carcinoma Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key merkel cell carcinoma companies including TuHURA Biosciences, Philogen, Immunomic Therapeutics, Phio Pharmaceuticals, AgonOx, Kymera Therapeutics, Merus N.V., among others. Renal Cell Carcinoma Market Renal Cell Carcinoma Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key renal cell carcinoma companies including AstraZeneca, Ipsen, Novartis, Pfizer, Amgen, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Drug ApprovalImmunotherapyBreakthrough Therapy

100 Deals associated with Futibatinib

External Link

KEGG	Wiki	ATC	Drug Bank
D11725	-	-	DB15149

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
FGFR2 fusion or rearranged Cholangiocarcinoma	Japan	Taiho Pharmaceutical Co., Ltd.	26 Jun 2023
Intrahepatic Cholangiocarcinoma	United States	Taiho Oncology, Inc.	30 Sep 2022

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Biliary Tract Neoplasms	NDA/BLA	Japan	Taiho Pharmaceutical Co., Ltd.	30 Jan 2022
Neoplasm Metastasis	Phase 3	United States	Taiho Oncology, Inc.	01 Oct 2024
Neoplasm Metastasis	Phase 3	France	Taiho Oncology, Inc.	01 Oct 2024
Neoplasm Metastasis	Phase 3	South Korea	Taiho Oncology, Inc.	01 Oct 2024
Neoplasm Metastasis	Phase 3	Spain	Taiho Oncology, Inc.	01 Oct 2024
Neoplasm Metastasis	Phase 3	United Kingdom	Taiho Oncology, Inc.	01 Oct 2024
Adenocarcinoma of Esophagus	Phase 2	United States	Taiho Oncology, Inc.	13 Jul 2023
Adenocarcinoma of Esophagus	Phase 2	France	Taiho Oncology, Inc.	13 Jul 2023
Adenocarcinoma of Esophagus	Phase 2	Germany	Taiho Oncology, Inc.	13 Jul 2023
Adenocarcinoma of Esophagus	Phase 2	Spain	Taiho Oncology, Inc.	13 Jul 2023

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04093362 (FOENIX-CCA3, CTgov)	Phase 3	FGFR2 fusion or rearranged Cholangiocarcinoma	10	Futibatinib	dfmqcypnfs = wciyouzojk mdaaqkrmlu (smrgprgrqh, ojjmqezyhg - tunqojdxpb) View more	-	07 Feb 2025
NCT04999761 (ASCO_GI2025) Manual	Phase 1	Metastatic Esophageal Carcinoma First line	43	Zimberelimab + Futibatinib + cisplatin + fluorouracil	gwtufaavav(tmdryjnvje) = DLTs were evaluated in the first three pts, and none were reported. zezymddekv (ukptbdpmgr )	Positive	23 Jan 2025
Phase 1b study of futibatinib plus pembrolizumab (ASCO_GI2025)	Phase 1	Esophageal Carcinoma CD3+ \| CD4 \| CD8+ ... View more	18	Futibatinib + Pembrolizumab	lsdjieehcf(fytsxrmdzi) = 22.2% ctkfcajdts (vkkoxgdnhf ) View more	Positive	23 Jan 2025
NCT04601857 (ESMO2024) Manual	Phase 2	Transitional Cell Carcinoma First line FGFR alteration	43	Futibatinib 20 mg PO QD Pembrolizumabzumab 200 mg IV Q3W	kqymafsljc(arngnpwgbg) = ghnezwyxbt ptzlhigatk (vqmihieaaw, 23 - 72) View more	Positive	15 Sep 2024
NCT04601857 (ESMO2024) Manual	Phase 2	Transitional Cell Carcinoma First line FGFR alteration	43	Futibatinib 20 mg PO QD+PembrolizumabPembrolizumab 200 mg IV Q3W (without FGFR3 mutations or FGFR1–4 fusion/rearrangements)	kqymafsljc(arngnpwgbg) = bjroxvenyu ptzlhigatk (vqmihieaaw, 14 - 52) View more	Positive	15 Sep 2024
NCT02052778 (FOENIX-CCA2, Pubmed \| Future Oncol) Manual	Phase 2	Advanced Bile Duct Carcinoma FGFR2 Fusion	-	Futibatinib	vvqubseswl(praiafzsjk) = itzbxyxeav mdstpggsnf (ytathlxjfu ) View more	Positive	17 Jun 2024
JPRN-jRCT2080224975 (ASCO2024) Manual	Phase 1	Esophageal Carcinoma	-	Futibatinib 2Pembrolizumabembrolizumab 200mg/q3w with chemotherapy	qgoopsxqbi(ojmlfoysvx) = juwdjgwdys lhauafyjrp (wywyinlrav, 43.4 - 87.4) View more	Positive	24 May 2024
JPRN-jRCT2080224975 (ASCO2024) Manual	Phase 1	Esophageal Carcinoma	-	Futibatinib 20Pembrolizumabmbrolizumab 200mg/q3w without chemotherapy	qgoopsxqbi(ojmlfoysvx) = vvedcgqffa lhauafyjrp (wywyinlrav, 26.3 - 60.6) View more	Positive	24 May 2024
JPRN-jRCT2080224975 (ESMO 12023 \| ESMO 22023) Manual	Phase 1	Esophageal Carcinoma	92	Futibatinib + pembrolizumab (ICI naïve)	dkjwceedje(mnvjzaogyn) = ixrclwjpne jihvearyoo (ifeohwlrsb ) View more	Positive	23 Oct 2023
JPRN-jRCT2080224975 (ESMO 12023 \| ESMO 22023) Manual	Phase 1	Esophageal Carcinoma	92	Futibatinib + pembrolizumab (ICI refractory)	dkjwceedje(mnvjzaogyn) = kblergieyj jihvearyoo (ifeohwlrsb ) View more	Positive	23 Oct 2023
TAS-120-101 (EMA) Manual	Not Applicable	FGFR2 fusion or rearranged Cholangiocarcinoma	103	futibatinib	qadqbdceat(ljsztlawzp) = auqohzcvpo cirxhumrwb (mlbujmgzme, 32 - 52) View more	Positive	18 Jul 2023
NCT02052778 (FOENIX-CCA2, ESMO_GI2023)	Phase 2	FGFR2 positive Intrahepatic Cholangiocarcinoma FGFR2	103	Futibatinib	mizunzefav(rkefdbtmde) = gcayqcznfn dmgmywqzxo (fgsdcdfiwy ) View more	Positive	01 Jul 2023
NCT04189445 (SO-10, ESMO_GI2023)	Phase 2	FGFR2 positive Gastrooesophageal Junction Cancer FGFR2 amplification	28	Futibatinib 20 mg	zcxcynvxbo(mknqdyogcb) = fmhmzcavmx yyclstnoph (wqtmdqqbzi, 6.1 - 36.9) View more	Positive	01 Jul 2023

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