Fruzaqla (fruquintinib) / Eli Lilly, Hutchmed, Takeda - LARVOL DELTA

Prophylactic effect of diclofenac sodium gel on hand-foot syndrome in patients with gastrointestinal cancer treated with tyrosine kinase inhibitors : A single-center prospective observational study (ESMO Asia 2025) - "Secondary endpoints included overall survival (OS), progression-free survival (PFS), safety, tolerability, and QOL (The HFS-14 questionnaire). Between January 2024 and May 2025, 31 patients were enrolled (median age: 67 years [range: 51-80]; male/female: 58%/42%; performance status [PS] 0/1/2: 36%/61%/3%; primary tumor site: colorectal/hepatocellular carcinoma/gastrointestinal stromal tumor: 77%/16%/7%; TKIs: regorafenib/lenvatinib/fruquintinib/sorafenib/sunitinib: 77%/10%/7%/3%/3%. Diclofenac sodium gel application did not reduce the incidence of TKIs-induced grade ≥2 HFS, compared to than the known reports of capecitabine-induced HFS. However, there were no grade≥ 3 HFS and treatment discontinuation due to HFS. Further research on the preventive effects of diclofenac sodium gel for HFS induced by TKIs is warranted."

Clinical • Observational data • Colorectal Cancer • Gastric Cancer • Gastrointestinal Cancer • Gastrointestinal Stromal Tumor • Hepatocellular Cancer • Oncology • Sarcoma • Solid Tumor

Feasibility and evaluation of functional drug sensitivity testing (DST) in relapsed/refractory gastrointestinal cancers (ESMO Asia 2025) - "For example, in a CRC case, Gemcitabine + Paclitaxel (NCV = 0.3269) showed greater sensitivity compared to Fruquintinib (NCV = 0.7987) and Regorafenib (NCV = 0.8225). This study confirms the feasibility of using Optim.AI® in GI cancers, providing interpretable drug sensitivity profile within 7 days. The identification of tumor-specific drug activity highlights the potential of Optim.AI® in guiding treatment decisions when standard options are limited due to disease progression. Further clinical validation is ongoing to establish its clinical concordance in GI cancer setting."

Gastric Cancer • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Solid Tumor

Real-world observational study of fruquintinib in combination with irinotecan and capecitabine as second-line treatment in patients with advanced colorectal cancer (ESMO Asia 2025) - P | "11 (52.4%) and 4 (19.0%) patients had received bevacizumab and cetuximab as part of their first-line treatment. These results show the preliminary efficacy and safety of fruquintinib in combination with irinotecan and capecitabine as a second-line treatment for patients with advanced colorectal cancer."

Clinical • Combination therapy • Metastases • Observational data • Real-world • Real-world evidence • Colorectal Adenocarcinoma • Colorectal Cancer • Oncology • Solid Tumor • UGT1A1

The efficacy and safety of fruquintinib(F) plus FOLFIRI as second-line(2L) treatment in bevacizumab(Bev)-pretreated RAS-mutated (RAS-m) metastatic colorectal cancer(mCRC) (ESMO Asia 2025) - P2 | "This study aimed to evaluate the efficacy and safety of F plus FOLFIRI as 2L therapy following first-line(1L) failure with bev plus oxaliplatin-based chemotherapy(chemo) (B-O) in RAS-m mCRC. This is a prospective, single-center, single-arm phase II study following Simon's two-stage design... F plus FOLFIRI demonstrated modest efficacy and manageable toxicity as 2L therapy for RAS-m mCRC with poor response to 1L B-O, warranting further study."

Clinical • Metastases • Colorectal Cancer • Oncology • Solid Tumor • FLT1 • RAS

Efficacy and safety of fruquintinib combined with PD-1 inhibitor and chidamide in MSS mCRC: A comparison with real-world bevacizumab plus anti-pd-1 and chidamide arm (ESMO Asia 2025) - P2 | "Fruquintinib combined with PD-1 antibody and chidamide shows promising signal in tumor responses, whilst survival benefit is not as expected in both arms based on current data. This ongoing study needs future explorations to figure out dominant subgroups."

Clinical • IO biomarker • Real-world • Real-world evidence • Colorectal Cancer • Oncology • FLT1

Fruquintinib combined with TAS-102 with or without SBRT as third- or later-line treatment in metastatic colorectal cancer : Preliminary results from a prospective phase II trial (ESMO Asia 2025) - P2 | "Fruquintinib combined with TAS-102 with or without SBRT showed promising preliminary efficacy and acceptable safety in third-or later-Line treatment in metastatic colorectal cancer, requiring confirmation in expanded studies."

Clinical • Metastases • P2 data • Colorectal Cancer • Oncology • Solid Tumor

Fruquintinib monotherapy as second-line (2L) treatment in locally advanced or metastatic renal cell carcinoma (RCC): Results from phase II part of FRUSICA-2 (ESMO Asia 2025) - P2/3 | "Background: FRUSICA-2 is a randomized, open-label, active-controlled phase 2/3 study (NCT05522231) designed to evaluate the efficacy and safety of Fruquintinib (F) + Sintilimab versus Axitinib or Everolimus monotherapy for 2L treatment of RCC. Results from this F monotherapy of the FRUSICA-2 indicated a comparable anti-tumor efficacy compared with other 2L VEGFR-TKI monotherapies, along with a manageable safety profile in 2L RCC pts after first-line VEGFR-TKI therapy."

Clinical • Metastases • Monotherapy • P2 data • Clear Cell Renal Cell Carcinoma • Genito-urinary Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

A systematic review of cost-effectiveness studies of later-line treatments for refractory metastatic colorectal cancer. (PubMed, Expert Rev Pharmacoecon Outcomes Res) - "Later-line treatments were generally not found to be cost-effective compared to BSC, mainly due to high drug costs. No treatment showed consistently favorable results across studies, with outcomes varying by comparator, country, and model settings."

HEOR • Journal • Review • Colorectal Cancer • Oncology • Solid Tumor

Sequencing fruquintinib and trifluridine/tipiracil to improve outcomes in the real-world management of MMR-proficient, chemo-refractory colorectal cancer in Hong Kong. (ASCO-GI 2026) - "The full, final text of this abstract will be available on Jan 05 at 05:00 PM EST."

Clinical • Real-world • Real-world evidence • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

The efficacy and safety of third-line regorafenib versus fruquintinib in the treatment of metastatic colorectal cancer: A meta-analysis. (ASCO-GI 2026) - "The full, final text of this abstract will be available on Jan 05 at 05:00 PM EST."

Metastases • Retrospective data • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

Short-course radiotherapy (SCRT) followed by immunochemotherapy plus fruquintinib as the total neoadjuvant therapy (TNT) for locally advanced rectal cancer (LARC): A multicenter, single-arm, open-label, phase II study (UNION TNT). (ASCO-GI 2026) - P2 | "Clinical Trial Registration Number: NCT06234007 The full, final text of this abstract will be available on Jan 05 at 05:00 PM EST."

Clinical • Metastases • P2 data • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Rectal Cancer • Solid Tumor

Number needed to treat/harm (NNT/NNH): A benefit/risk analysis of fruquintinib vs other treatments for metastatic colorectal cancer (mCRC). (ASCO-GI 2026) - P3 | "Funded by Takeda Pharmaceuticals U.S.A., Inc, Cambridge, MA, USA Clinical Trial Registration Number: NCT02314819, NCT04322539, NCT01584830, NCT01103323, NCT01955837, NCT01607957 The full, final text of this abstract will be available on Jan 05 at 05:00 PM EST."

Metastases • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

Fruquintinib and pirfenidone in combination with anti-PD-1 antibody in pMMR/MSS metastatic colorectal carcinoma: A prospective, single-arm, phase Ib/II trial. (ASCO-GI 2026) - P1/2 | "Clinical Trial Registration Number: NCT06484153 The full, final text of this abstract will be available on Jan 05 at 05:00 PM EST."

Clinical • Combination therapy • Metastases • P1/2 data • pMMR • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

Final results of a phase II study of fruquintinib plus sintilimab as a second-line therapy for advanced gastric and gastroesophageal junction adenocarcinoma (GC/GEJC). (ASCO-GI 2026) - P2 | "Clinical Trial Registration Number: NCT05625737 The full, final text of this abstract will be available on Jan 05 at 05:00 PM EST."

Clinical • Metastases • P2 data • Esophageal Cancer • Gastric Cancer • Gastroesophageal Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Oncology • Solid Tumor

Phase Ib/II study of fruquintinib combined with SOX and toripalimab in advanced metastatic gastric/gastroesophageal junction adenocarcinoma (GC/GEJC). (ASCO-GI 2026) - P1/2 | "Clinical Trial Registration Number: NCT05024812 The full, final text of this abstract will be available on Jan 05 at 05:00 PM EST."

Metastases • P1/2 data • Esophageal Cancer • Gastric Cancer • Gastroesophageal Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Oncology • Solid Tumor

Matching-adjusted indirect comparison of fruquintinib versus ramucirumab in advanced gastric or gastroesophageal junction adenocarcinoma. (ASCO-GI 2026) - P | "Funded by HUTCHMED Pharmaceutical Company Clinical Trial Registration Number: NCT07144995 The full, final text of this abstract will be available on Jan 05 at 05:00 PM EST."

Metastases • Esophageal Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Oncology • Solid Tumor

A multi-center phase 1b/2 clinical trial of concurrent administration of fruquintinib and FTD/TPI in patients with previously treated unresectable metastatic colorectal cancer and gastric cancer (FACT). (ASCO-GI 2026) - "Clinical Trial Registration Number: jRCT2031240630 The full, final text of this abstract will be available on Jan 05 at 05:00 PM EST."

Clinical • Metastases • P1/2 data • Colorectal Cancer • Gastric Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

The Current Role of Antiangiogenics in Colorectal Cancer. (PubMed, Int J Mol Sci) - "Among emerging therapies, the novel anti-angiogenic agent fruquintinib has recently demonstrated clinical efficacy in the treatment of mCRC. Based on the data discussed in the present narrative review, the therapeutic landscape of mCRC appears poised for significant evolution in the near future. While numerous challenges and unanswered questions remain, the emergence of innovative therapeutic combinations and agents provides a promising opportunity for improving patient outcomes in mCRC."

Journal • Review • Colorectal Cancer • Oncology • Solid Tumor • BRAF • MSI

concept: The Safety and Efficacy of Cetuximab Beta Plus Fruquintinib With or Without Immune Checkpoint Inhibitorrs in First-line Treatment of RAS/BRAF Wild Type Unresectable Metastatic Colorectal Cancer (clinicaltrials.gov) - P2 | N=70 | Recruiting | Sponsor: Zhejiang University

Checkpoint inhibition • IO biomarker • New P2 trial • Colorectal Cancer • Oncology • Solid Tumor • BRAF

FRUQUITAS: Trifluridine/Tipiracil + Fruquintinib Versus Trifluridine/Tipiracil Alone for Metastatic Oeso-gastric Adenocarcinoma (clinicaltrials.gov) - P3 | N=324 | Not yet recruiting | Sponsor: Federation Francophone de Cancerologie Digestive

New P3 trial • Gastric Adenocarcinoma • Gastric Cancer • Oncology • Solid Tumor

HUTCHMED (China) Limited…announces that following the contract renewal with the China National Healthcare Security Administration ('NHSA'), the updated National Reimbursement Drug List ('NRDL') effective on January 1, 2026 will continue to include ELUNATE… (GlobeNewswire) - "ELUNATE (fruquintinib) is included for the treatment of patients with advanced endometrial cancer with Mismatch Repair proficient (pMMR) tumors that have failed prior systemic therapy and are not candidates for curative surgery or radiation, in combination with TYVYT (sintilimab injection). It is also renewed for the treatment of patients with metastatic colorectal cancer who have previously received fluoropyrimidine, oxaliplatin and irinotecan-based chemotherapy, and those who have previously received or are not suitable for receiving anti-VEGF therapy or anti-epidermal growth factor receptor (EGFR) therapy (RAS wild-type)."

pMMR • Reimbursement • Colorectal Cancer • Endometrial Cancer

Results from a Fruquintinib Monotherapy Cohort in FRUSICA-1: a Phase 2 Study of Fruquintinib plus Sintilimab in Treated Advanced Endometrial Cancer (EMC) [WITHDRAWN] (ESMO Asia 2025) - No abstract available

Metastases • Monotherapy • P2 data • Endometrial Cancer • Oncology • Solid Tumor

Tislelizumab combined with fruquintinib and chidamide in later-line treatment of unresectable or advanced colorectal cancer with liver metastases (CRLM): Preliminary results of a single-arm, phase II trial (ESMO-IO 2025) - P2 | "Background The combination of a PD-1 inhibitor, chidamide, and bevacizumab significantly improves efficacy in patients with proficient mismatch repair (pMMR)/microsatellite stable (MSS) colorectal cancer in later-line treatment (Xu R, et al. The most common ≥10% experienced treatment-emergent adverse events included thrombocytopenia (57.1%), hypothyroidism (42.9%), and rash (14.3%). No new safety signals were identified.Conclusions The combination of tislelizumab, fruquintinib and chidamide showed promising antitumor activity and a manageable safety profile in later-line treatment of MSS/pMMR CRLM patients.Clinical trial identification NCT06218888.Legal entity responsible for the study The author."

IO biomarker • Metastases • P2 data • Colorectal Cancer • Oncology • Solid Tumor

Updated results of stereotactic body radiation therapy followed by fruquintinib in combination with immunotherapy as third- and later-line treatment in metastatic colorectal cancer (ESMO-IO 2025) - P2 | "One week later, fruquintinib would be administered with an oral daily dose of 3-5 mg on days 1-14 in combination with sintilimab 200 mg intravenously once for day 1 using a 21-day cycle. Any grade TRAEs included fatigue (56.7%), hypoalbuminemia (50%), hypertension (36.7%), Platelet count decreased (36.7%), Pneumonia (30%). Grade 3/4 TEAEs were mainly Pneumoni(n=2), fatigue(n=1), Hypoalbuminemia(n=1).Conclusions SBRT followed by fruquintinib in combination with immunotherapy yielded a promising efficacy and acceptable safety as third- and later-line treatment in mCRC, which warrants further large-scale studies.Clinical trial identification ChiCTR2300071037.Legal entity responsible for the study The authors."

Combination therapy • Metastases • Colorectal Cancer • Oncology • Solid Tumor

A Study to Monitor the Fruzaqla Treatment of Adults With Metastatic Colorectal Cancer (mCRC) in South Korea (clinicaltrials.gov) - P=N/A | N=600 | Recruiting | Sponsor: Takeda | Not yet recruiting ➔ Recruiting

Enrollment open • Colorectal Cancer • Oncology • Solid Tumor