Tag: FGFR3

Two Million Cancers; Casgevy OK’d for Thalassemia; Rectal Exams and Prostate Cancer

While cancer mortality continues to decline, the number of new cases is projected to top 2 million in 2024, according to the American Cancer Society’s annual report on cancer statistics. The FDA approved exagamglogene autotemcel (Casgevy) for transfusion-dependent beta thalassemia in patients 12 years and older, maker Vertex announced. This…

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FDA Approves Erdafitinib for FGFR3+ Locally Advanced or Metastatic Urothelial Carcinoma

The FDA has approved erdafitinib (Balversa) for adult patients with locally advanced or metastatic urothelial carcinoma harboring susceptible FGFR3 alterations, as determined by an FDA-approved test, whose disease has progressed on or following at least 1 prior line of systemic therapy. The agent is not recommended for those who are…

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FDA Approves Erdafitinib for Locally Advanced or Metastatic Urothelial Carcinoma With FGFR3 Mutations

FDA Approves Erdafitinib for Locally Advanced or Metastatic Urothelial Carcinoma With FGFR3 Mutations The FDA has approved erdafitinib (Balversa) for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma with susceptible FGFR3 genetic mutations whose disease has progressed on or after previously receiving one line of systemic…

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FDA Approves Balversa for Locally Advanced, Metastatic Urothelial Carcinoma

Image credit: Matthieu | stock.adobe.com The FDA has approved Balversa (erdafitinib) for adults with locally advanced or metastatic urothelial carcinoma with susceptible FGFR3 genetic mutations whose disease progressed on or following one line of systemic therapy.1 The regulatory action amends the accelerated approval granted by the FDA in April 2019 for patients…

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FDA grants full approval to erdafitinib for FGFR3-positive urothelial carcinoma

The FDA has granted a full approval to erdafitinib (Balversa) for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma with susceptible FGFR3 genetic alterations whose disease has progressed on or after at least 1 line of prior systemic therapy. It is not recommended for patients who,…

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cfDNA Extraction Sensitivity Controls – cfDNA Extraction Sensitivity Controls

Does your cfDNA extraction process affect the Limit of Detection (LOD) of a particular gene target? Our new products, cfDNA Extraction Sensitivity Panels and Extraction Low Positive Controls, can help your research and development for liquid biopsy assays. NEW PRODUCTS: cfDNA EXTRACTION SENSITIVITY PANELS &  CONTROLS The Extraction Sensitivity Controls…

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What is Chromosome 4?

Chromosome 4 is the fourth largest of the 23 pairs of chromosomes in humans. Chromosome 4 is made up of over 186 million base pairs, the building blocks of DNA which are tightly packed and super coiled to from the DNA helix. Chromosome 4 represents around 6% to 6.5% of…

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Eisai Submits Marketing Authorization Application in Japan for Anticancer Agent Tasurgratinib for Biliary Tract Cancer with Fgfr2 Gene Fusion

TOKYO, Dec 19, 2023 – (JCN Newswire) – Eisai Co., Ltd. announced today that it has submitted a marketing authorization application in Japan for its in-house discovered fibroblast growth factor (FGF) receptor (FGFR1, FGFR2, FGFR3) selective tyrosine kinase inhibitor tasurgratinib succinate (generic name, development code: E7090, “tasurgratinib”) for biliary tract…

Continue Reading Eisai Submits Marketing Authorization Application in Japan for Anticancer Agent Tasurgratinib for Biliary Tract Cancer with Fgfr2 Gene Fusion

Eisai files biliary tract cancer drug tasurgratinib in Japan

Eisai has filed for approval in Japan for tasurgratinib, its small-molecule fibroblast growth factor (FGF) receptor inhibitor, as a treatment for biliary tract cancers with FGFR2 gene fusion mutations. The application to the Ministry of Health, Labour and Welfare (MHLW) is set for a priority review, reflecting the relatively high…

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BridgeBio Announces First Child Dosed in PROPEL 3, its Phase 3 Clinical Trial for Infigratinib in Children with Achondroplasia

– BridgeBio has dosed the first child in PROPEL 3, a one-year, 2:1 randomized, placebo-controlled Phase 3 pivotal trial evaluating the efficacy and safety of infigratinib in children with achondroplasia –  The U.S. Food and Drug Administration (FDA) and European Union (EU) European Medicines Agency (EMA) shared positive feedback that…

Continue Reading BridgeBio Announces First Child Dosed in PROPEL 3, its Phase 3 Clinical Trial for Infigratinib in Children with Achondroplasia

BridgeBio Announces First Child Dosed in PROPEL 3, its Phase 3 Clinical Trial for Infigratinib in Children with Achondroplasia -December 13, 2023 at 07:31 am EST

Official BRIDGEBIO PHARMA, INC. press release – BridgeBio has dosed the first child in PROPEL 3, a one-year, 2:1 randomized, placebo-controlled Phase 3 pivotal trial evaluating the efficacy and safety of infigratinib in children with achondroplasia –  The U.S. Food and Drug Administration (FDA) and European Union (EU) European Medicines…

Continue Reading BridgeBio Announces First Child Dosed in PROPEL 3, its Phase 3 Clinical Trial for Infigratinib in Children with Achondroplasia -December 13, 2023 at 07:31 am EST

Endometrial cancer PDX-derived organoids (PDXOs) and PDXs with FGFR2c isoform expression are sensitive to FGFR inhibition

Patients, tumour Implantation, PDX expansion and characterization The study was conducted according to the Declaration of Helsinki. Tumours were collected from EC patients following Human Research Ethics Committee (HREC) approval (HREC/15/MHS/127) and QUT HREC (#1500000169, 1500000323). All participants provided written informed consent that their excess tissue could be used for…

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Cancer Blood Tests Can Jumpstart Diagnoses and Targeted Therapy

Register for free to listen to this article Thank you. Listen to this article using the player above. ✖ Want to listen to this article for FREE? Complete the form below to unlock access to ALL audio articles. New research led by a UC Davis Comprehensive Cancer Center clinical…

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Cancer blood tests jumpstart diagnoses and targeted therapy

Pathology of liver segment II biopsy and bone (spine) T9 metastases. A, B Biopsy of liver lesion at time of UC diagnosis, showing reactive hepatocytes (upper left) and metastatic UC (lower half), with hemorrhage and necrosis (lower left). Hematoxylin & Eosin stain, low power. Scale bar represents 1 mm (A). In…

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Most large structural variants in cancer genomes can be detected without long reads

JaBbA v1 outperforms previous CN algorithms We enhanced our previous JaBbA (v0.1; ref. 4) model with several methodological innovations to increase robustness to read depth waviness, improve algorithm convergence and enforce junction balance for allele-specific as well as total CN (Extended Data Fig. 1a–d and Methods). We also rigorously defined…

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Relay: Market Underestimating Lirafugratinib’s Potential (Upgrade) (RLAY)

Anchiy At a Glance Relay Therapeutics (NASDAQ:RLAY) has reached a critical phase, juxtaposing strong financial foundations against increasing operational costs, which I have previously analyzed in depth. Since my last evaluation, lirafugratinib’s clinical momentum has been maintained in the Phase 1/2 ReFocus trial, showing significant promise for FGFR2-altered cholangiocarcinoma, although…

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Phase 3 THOR Study & THOR-2 Cohort 1

(UroToday.com) The 2023 ESMO annual meeting included a session on urothelial carcinoma, featuring a discussant presentation by Dr. Michiel Van der Heijden. For this presentation, Dr. Van der Heijden discussed the abstract “Phase 3 THOR Study: Results of Erdafitinib vs Pembrolizumab in Pretreated Patients with Advanced or Metastatic Urothelial Cancer…

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Fibroblast Growth Factor Receptor 2 (FGFR2), a New Gene Involved in the Genesis of Autism Spectrum Disorder

The ASD patient described here showed a mutation in the FGFR2 gene, located in the chromosomal band 10q26 (Fig. 1a) and encoding the fibroblast growth factor receptor type 2. It belongs to the family of tyrosine kinase receptors (including FGFR1, FGFR3, and FGFR4) that regulate several biological processes, including bone development,…

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A urinary assay for mutation and methylation biomarkers in the diagnosis and recurrence prediction of non-muscle invasive bladder cancer patients | BMC Medicine

Wong MCS, Fung FDH, Leung C, Cheung WWL, Goggins WB, Ng CF. The global epidemiology of bladder cancer: a joinpoint regression analysis of its incidence and mortality trends and projection. Sci Rep. 2018;8(1):1129. Article  PubMed  PubMed Central  Google Scholar  Burger M, Catto JW, Dalbagni G, Grossman HB, Herr H, Karakiewicz…

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August 2023 Recap: Drug Pipeline Updates

Drug Pharmacologic Class Proposed Indication Status Allergic Disorders Remibrutinib (Novartis) Bruton tyrosine kinase inhibitor Treatment of chronic spontaneous urticaria in patients inadequately controlled by second generation H1 antihistamines. Phase 3 results Endocrine Disorders…

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Clinical and genomic landscape of FGFR3-altered urothelial carcinoma and treatment outcomes with erdafitinib: a real-world experience | Clinical Cancer Research

Citation Brendan J. Guercio, Michal Sarfaty, Min Yuen Teo, Neha Ratna, Cihan Duzgol, Samuel A. Funt, Chung-Han Lee, David H. Aggen, Ashley M. Regazzi, Ziyu Chen, Michael Lattanzi, Hikmat A. Al-Ahmadie, A. Rose Brannon, Ronak Shah, Carissa Chu, Andrew T. Lenis, Eugene Pietzak, Bernard H. Bochner, Michael F. Berger, David…

Continue Reading Clinical and genomic landscape of FGFR3-altered urothelial carcinoma and treatment outcomes with erdafitinib: a real-world experience | Clinical Cancer Research

Dr. Zhang on the THOR trial of erdafitinib in urothelial carcinoma

In this video, Tian Zhang, MD, associate professor of Medicine at UT Southwestern Medical Center, discusses the phase 3 THOR trial (NCT03390504), which showed that erdafitinib significantly improved overall survival compared with investigator’s choice of chemotherapy in patients with FGFR2/3-altered metastatic urothelial cancer who had previously received an anti–PD-(L)1 therapy.1,2…

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Janssen Seeks Approval for Balversa to Patients With Bladder Cancer

A supplemental New Drug Application (sNDA) has been submitted to the U.S. Food and Drug Administration for the approval of Balversa (erdafitinib) to treat patients with locally advanced or metastatic urothelial carcinoma with FGFR3 or FGFR2 gene alterations, and progressed on a prior checkpoint inhibitor or within 12 months of…

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J&J (JNJ) Seeks Full FDA Nod for Balversa in Urothelial Cancer

Johnson & Johnson JNJ announced that it has submitted a supplemental new drug application (sNDA) to the FDA seeking full approval for Balversa (erdafitinib) as a treatment for patients with metastatic or unresectable urothelial carcinoma (UC), a type of bladder cancer. Balversa, a kinase inhibitor, was approved by the FDA under…

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Full FDA approval sought for erdafitinib for urothelial carcinoma

A supplemental New Drug Application (sNDA) has been filed with the FDA for the full approval of erdafitinib (Balversa) for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma harboring a susceptible FGFR3 alteration and disease progression after ≥1 PD-1/PD-L1 inhibitor in the locally advanced or metastatic…

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Janssen Seeks Full Approval for Erdafitinib in Metastatic Bladder CA

Janssen has submitted a supplemental New Drug Application (sNDA) to the Food and Drug Administration (FDA) seeking full approval of erdafitinib (Balversa) for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC), that has susceptible fibroblast growth factor receptor (FGFR)3 genetic alterations, and progressed during or following…

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Janssen Seeks Full Approval for Balversa in FGFR3-Altered Bladder Cancer

NEW YORK – Janssen said on Monday that it is seeking full approval in the US for Balversa (erdafitinib) as a treatment for patients with FGFR3-altered locally advanced or metastatic urothelial carcinoma after progressing on an anti-PD-1/PD-L1 therapy in the metastatic setting or within a year of neoadjuvant or adjuvant…

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Dr Petrylak on Sequencing Questions in FGFR2/3-Altered Metastatic Urothelial Cancer

Daniel P. Petrylak, MD, professor, medicine, Medical Oncology and Urology, chief, Genitourinary Oncology, Yale School of Medicine, discusses sequencing treatment selections in patients with FGFR2/3-altered metastatic urothelial cancer. The optimal treatment sequencing for patients following a diagnosis of FGFR2/3-altered metastatic urothelial cancer remains unclear, Petrylak beings. Sequencing issues will arise…

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Rhox6 regulates the expression of distinct target genes to mediate mouse PGCLC formation and ESC self-renewal | Cell & Bioscience

Overexpression of Rhox6 promotes PGCLC formation To discover potential candidate genes that may be important for the specification of mouse PGCs, we analyzed the transcriptional data of E9.5 PGCs and epiblasts and found that the homeobox family members Rhox6 and Rhox9, as well as the PGC markers Prdm14, Blimp1, Stella…

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IJMS | Free Full-Text | DNA Methylation in the Fields of Prenatal Diagnosis and Early Detection of Cancers

1. DNA Methylation: Looking Back over the Century “Genes are equivalent to blueprints; epigenetics is the contractor. They change the assembly, the structure.” —Bruce Lipton. The methylation of the DNA is a quintessential epigenetic mechanism consisting of the binding of a methyl group to the fifth carbon of the cytosine…

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r – Adding variants from amplicon sequenced data to MAF file generated by WES data

I am relatively new to bioinformatics, and I need some help with adding variants from a specific gene that were sequenced using amplicon data (due to bad sequencing in a hot spot) to a MAF (Mutation Annotation Format) file. The MAF file I have is entirely generated from WES (Whole…

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Dr Sonpavde on the Potential Impact of the THOR Study in FGFR2/3-Altered Urothelial Carcinoma

Guru P. Sonpavde, MD, medical director, Genitourinary (GU) Oncology, assistant director, Clinical Research Unit, Christopher K. Glanz Chair, Bladder Cancer Research, AdventHealth Cancer Institute, discusses the potential impact of the phase 3 THOR study (NCT03390504) evaluating erdafitinib (Balversa) vs chemotherapy in patients with advanced or metastatic urothelial cancer harboring FGFR2/3…

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A Phase 1 Study of KIN-3248 in People With Solid Tumors

Full Title A Phase 1/1b, Open-label, Multicenter Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Anti-tumor Activity of KIN-3248 in Participants with Advanced Tumors Harboring FGFR2 and/or FGFR3 Gene Alterations Purpose The purpose of this study is to find the best dose of KIN-3248 to treat advanced biliary tract…

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Genomic Heterogeneity as a Barrier to Precision Oncology in Urothelial Cancer

Read the Full Video Transcript Sam Chang: Hello everyone, I’m Sam Chang. I’m a urologist at Vanderbilt University in Nashville, Tennessee and we’re quite fortunate to have a rising superstar in urologic oncology, Dr. Tim Clinton. Tim was a resident at UT Southwestern and finished his fellowship at Memorial Sloan…

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Solved Short-limb dwarfism in humans is caused by a missense

Transcribed image text: Short-limb dwarfism in humans is caused by a missense mutation in the human FGFR2 gene, resulting in a gain of function, constitutively active FGF receptor protein. a) Diagram a knockin construct that could have been used to create the mouse model for achondroplasia shown below. Achondroplastic dwarfism…

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Janssen shares positive phase 3 results for erdafitinib in bladder cancer

The Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen) has shared positive results from a late-stage study of erdafitinib in urothelial carcinoma, the most common type of bladder cancer. Urothelial carcinoma accounts for approximately 90% of bladder cancer cases, and up to 20% of patients diagnosed with metastatic urothelial carcinoma…

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Erdafitinib Bests Chemotherapy in FGFR-Altered Metastatic Urothelial Carcinoma

Erdafitinib improves survival outcomes when compared to chemotherapy in patients with metastatic urothelial carcinoma and select FGFR alterations who were previously treated with immune checkpoint inhibitors, according to results from the phase 3 THOR trial.  These results support erdafitinib as a standard of care option for these patients and support…

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Erdafitinib Confers OS Benefit in FGFR-Altered Urothelial Cancer

Erdafitinib (Balversa) reduced the risk of death by 36% vs investigator’s choice of chemotherapy in patients with FGFR2/3-altered metastatic urothelial cancer who were previously treated with anti–PD-1 therapy, according to findings from the phase 3 THOR trial (NCT03390504). The results were presented in a late-breaking abstract session during the 2023…

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Erdafitinib extends survival in post-immunotherapy, FGFR-altered urothelial cancer

Findings form the phase 3 THOR trial (NCT03390504) presented during the 2023 ASCO Annual Meeting showed that erdafitinib (Balversa) significantly improved overall survival compared with investigator’s choice of chemotherapy in patients with FGFR2/3-altered metastatic urothelial cancer who had previously received an anti–PD-(L)1 therapy.1 “The phase 3 THOR study supports the…

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Exploring Tumor Biomarkers in Urothelial Carcinoma: Insights and Advancements in Bladder Cancer Research

Read the Full Video Transcript Sam Chang: Hello everyone. My name is Sam Chang. I’m a urologist in Nashville, Tennessee and work at Vanderbilt University Medical Center. And we’re quite fortunate to have Dr. Chad Ritch from the University of Miami. I’ve known Chad a long time. He’s an associate…

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Dr Kim on the Investigation of RLY-4008 in FGFR2+ Cholangiocarcinoma

Richard Kim, MD, service chief, Medical Gastrointestinal Oncology, senior member, professor, the Gastrointestinal Oncology Department, Moffitt Cancer Center, discusses the investigation of RLY-4008 for the treatment of patients with cholangiocarcinoma harboring an FGFR2 fusion or rearrangement. RLY-4008 is a highly selective, irreversible FGFR2 inhibitor currently under evaluation in the phase…

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Ongoing Investigation of RLY-4008 Highlights Evolving Treatment Options for FGFR2+ Cholangiocarcinoma

R. Kate (Katie) Kelley, MD The selective FGFR2 inhibitor RLY-4008 has generated higher response rates compared with historical data for prior pan-FGFR inhibitors in patients with cholangiocarcinoma harboring FGFR2 fusions or alterations who have not been exposed to a prior FGFR inhibitor, according to R. Kate (Katie) Kelley, MD. Data…

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Kinnate Bio: Novel Approach To BRAF Class II And III, But Uninspiring Data (NASDAQ:KNTE)

naphtalina/iStock via Getty Images Kinnate Biopharma (NASDAQ:KNTE) develops small molecule kinase inhibitors to treat genomically defined cancers. The company has two molecules in the clinic, exarafenib and KIN-3248. Exarafenib is an oral, small molecule pan-RAF inhibitor. It is in a phase 1 trial in patients with advanced solid tumors harboring…

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FGFR2 modulates the Akt/Nrf2/ARE signaling pathway to improve angiotensin II-induced hypertension-related endothelial dysfunction

Introduction Hypertension is one of the main risk factors of cardiovascular disease. According to the Chinese hypertension survey, the prevalence rate of adult hypertension in China is 27.9%, showing an increasing trend and the awareness rate, treatment rate and control rate are respectively 51.6%, 45.8% and 16.8% (Citation1). Compared with…

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Convergent genomic diversity and novel BCAA metabolism in intrahepatic cholangiocarcinoma

Multi-omics analyses of the ICC samples Following multiregional sampling of primary ICC cases, we performed multi-omics analyses, including genome, transcriptome, proteome, and metabolome analysis. We used 10 (67 samples), 11 (88 samples), 10 (49 samples) and 10 (49 samples) ICC cases for WES, whole-transcriptome sequencing, proteomic analysis, and metabolomic analysis,…

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The prognostic value of hedgehog signaling in bladder cancer by integrated bioinformatics

HhS activation is a marker of poor prognosis in BLCA patients First, HhS scores were calculated and its expression characteristics were analyzed for patients in the TGCA-BLCA cohort. The results showed that HhS was overactivated in patients with higher stage and older age (Fig. 2A, B). And there is no significant…

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Specific recognition of an FGFR2 fusion by tumor infiltrating lymphocytes from a patient with metastatic cholangiocarcinoma

Introduction Cholangiocarcinoma (CC) is a form of gastrointestinal cancer that originates from the epithelium of either intrahepatic or extrahepatic bile ducts. It accounts for approximately 3% of all gastrointestinal cancers, with reported incidence of one to two cases per 100,000 persons per year in the USA (and much higher incidence…

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The evolution of lung cancer and impact of subclonal selection in TRACERx

The TRACERx 421 cohort The TRACERx study (clinicaltrials.gov/ct2/show/NCT01888601) is a prospective observational cohort study that aims to transform our understanding of NSCLC, the design of which has been approved by an independent research ethics committee (13/LO/1546). Informed consent for entry into the TRACERx study was mandatory and obtained from every…

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OTUB1 promotes osteoblastic bone formation through stabilizing FGFR2

OTUB1 deficiency causes defects in osteogenesis To determine the physiological role of OTUB1 in bone homeostasis, Otub1 global knockout mice (referred to as Otub1−/−) were constructed, and their phenotypes were analyzed on embryonic (E) day 14.5 (E14.5), E16.5, E18.5, and postnatal (P) day P0 (Fig. 1a and Supplementary Fig. 1a,…

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Estimates a Diverse Cholangiocarcinoma Pipeline Comprising 70+ Companies Working in the Domain | Major Companies

PRESS RELEASE Published April 5, 2023 DelveInsight’s, “Cholangiocarcinoma Pipeline Insight 2023,” report provides comprehensive insights about 70+ companies and 70+ pipeline drugs in the Cholangiocarcinoma pipeline landscape. It covers the Cholangiocarcinoma pipeline drug profiles, including Cholangiocarcinoma clinical trials and nonclinical stage products. It also covers the Cholangiocarcinoma pipeline therapeutics assessment…

Continue Reading Estimates a Diverse Cholangiocarcinoma Pipeline Comprising 70+ Companies Working in the Domain | Major Companies

Urothelial Carcinoma Pipeline Assets and Comparative Analysis of Clinical and Non-Clinical Stage Products

PRESS RELEASE Published March 13, 2023 DelveInsight’s, “Urothelial Carcinoma Pipeline Insight, 2023,” report provides comprehensive insights about 40+ companies and 50+ pipeline drugs in the Urothelial Carcinoma pipeline landscape. It covers the Urothelial Carcinoma pipeline drug profiles, including Urothelial Carcinoma clinical trials and nonclinical stage products. It also covers the…

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DelveInsight Estimates a Diverse Cholangiocarcinoma Pipeline Comprising 70+ Companies Working in the Domain

PRESS RELEASE Published March 2, 2023 DelveInsight’s, “Cholangiocarcinoma Pipeline Insight, 2023,” report provides comprehensive insights about 70+ companies and 70+ pipeline drugs in the Cholangiocarcinoma pipeline landscape. It covers the Cholangiocarcinoma pipeline drug profiles, including Cholangiocarcinoma clinical trials and nonclinical stage products. It also covers the Cholangiocarcinoma pipeline therapeutics assessment…

Continue Reading DelveInsight Estimates a Diverse Cholangiocarcinoma Pipeline Comprising 70+ Companies Working in the Domain

Discovery of Orally Bioavailable FGFR2/FGFR3 Dual Inhibitors via Structure-Guided Scaffold Repurposing Approach

CITE THIS COLLECTION DataCite3 Biotech3D Printing in Medicine3D Research3D-Printed Materials and Systems4ORAAPG BulletinAAPS OpenAAPS PharmSciTechAbhandlungen aus dem Mathematischen Seminar der Universität HamburgABI Technik (German)Academic MedicineAcademic PediatricsAcademic PsychiatryAcademic QuestionsAcademy of Management DiscoveriesAcademy of Management JournalAcademy of Management Learning and EducationAcademy of Management PerspectivesAcademy of Management ProceedingsAcademy of Management Review Nguyen, Minh…

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Genomic Analysis Yields ‘Hypothesis Generating’ Data in Bladder Cancer Subtype

During the 2023 Genitourinary Cancer Symposium, CancerNetwork® spoke with Shilpa Gupta, MD, a genitourinary oncologist from Case Comprehensive Cancer Center, regarding biomarkers of response and resistance to treatment with nivolumab (Opdivo) and chemotherapy in muscle-invasive bladder cancer. Data from a genomic correlative analysis of the phase 2 BLASST-1 trial (NCT03294304)…

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FLI1 and FRA1 transcription factors drive the transcriptional regulatory networks characterizing muscle invasive bladder cancer

Sung, H. et al. Global Cancer Statistics 2020: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J. Clin. 71, 209–249 (2021). Article  PubMed  Google Scholar  Sanli, O. et al. Bladder cancer. Nat. Rev. Dis. Prim. 3, 17022 (2017). Article  PubMed  Google Scholar  International…

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Kinnate’s CCA therapy KIN-3248 receives FDA Fast Track status

Micrograph of cholangiocarcinoma. Credit: Nephron / Wikimedia. Kinnate Biopharma has received Fast Track designation from the US Food and Drug Administration (FDA) for its pan-FGFR inhibitor, KIN-3248, to treat unresectable, locally advanced or metastatic cholangiocarcinoma (CCA). KIN-3248 is indicated to treat CCA harbouring fibroblast growth factor receptor 2 (FGFR2) gene…

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Futibatinib for FGFR2+ Advanced Cholangiocarcinoma Hits the Market

Futibatinib (Lytgobi) is now available for the treatment of adult patients with previously treated, unresectable, locally advanced or metastatic intrahepatic cholangiocarcinoma harboring fibroblast growth factor receptor 2 (FGFR2) gene fusions or other rearrangements.1 Previously in September 2022, the FDA granted an accelerated approval to the kinase inhibitor futibatinib in this…

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Oppenheimer Says These 2 Stocks Have Double-Digit Gains in Sight

2023 is well underway now, and the key story is the sudden change in sentiment on the financial front. Last year’s bearish trend and headwinds are well known. Stubborn inflation, the Fed’s rapid increase in interest rates, the risk of recession, China’s shutdowns, and Russia’s Ukraine invasion; they all weighed…

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Cholangiocarcinoma Pipeline Appears Robust With 70+ Key Pharma Companies Actively Working in the Therapeutics Segment

PRESS RELEASE Published January 24, 2023 DelveInsight’s, “Cholangiocarcinoma Pipeline Insight, 2023,” report provides comprehensive insights about 70+ companies and 70+ pipeline drugs in the Cholangiocarcinoma pipeline landscape. It covers the pipeline drug profiles, including Cholangiocarcinoma clinical trials and nonclinical stage products. It also covers the therapeutics assessment by product type,…

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Derazantinib Shows Clinical Benefit, Manageable Safety Profile in Patients With Cholangiocarcinoma

Derazantinib is an investigational oral inhibitor of FGFR1, FGFR2, and FGFR3 in patients with locally advanced or metastatic intrahepatic cholangiocarcinoma. Treatment with derazantinib, an FGFR inhibitor, produced a meaningful clinical benefit with a manageable safety profile in patients with locally advanced or metastatic intrahepatic cholangiocarcinoma (iCCA), according to data from…

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Dementia with Lewy bodies post-mortem brains reveal differentially methylated CpG sites with biomarker potential

Weisman, D. & McKeith, I. Dementia with Lewy Bodies. Semin. Neurol. 27, 042–047 (2007). Article  Google Scholar  Foguem, C. & Manckoundia, P. Lewy Body Disease: Clinical and Pathological “Overlap Syndrome” Between Synucleinopathies (Parkinson Disease) and Tauopathies (Alzheimer Disease). Curr. Neurol. Neurosci. Rep. 2018 18:5 18, 1–9 (2018). CAS  Google Scholar …

Continue Reading Dementia with Lewy bodies post-mortem brains reveal differentially methylated CpG sites with biomarker potential

Pemigatinib Improves OS in FGFR2-Altered Cholangiocarcinoma

A survival benefit was elicited with the use of pemigatinib when used for patients with previously treated advanced cholangiocarcinoma who had an FGFR2 fusion or rearrangement. Pemigatinib (Pemazyre) showed a strong survival benefit in patients with previously treated advanced cholangiocarcinoma who had an FGFR2 fusion or rearrangement, according to final…

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Dosing of KIN-3248 Begins in Advanced Solid Tumors With FGFR2 and/or FGFR3 Alterations

The first patient has been dosed in the phase 1 KN-4802 trial (NCT05242822) examining the safety, tolerability, and preliminary efficacy of KIN-3248, a next-generation pan-FGFR inhibitor, in adult patients with advanced tumors harboring FGFR2 and/or FGFR3 gene alterations, according to a press release from Kinnate Biopharma Inc.1 KIN-3248 is an…

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First Patient Treated in Study to Determine Tolerability, Dosing of Investigational Drug in Certain Solid Tumors

The first patient has received a dose of a novel drug candidate in an early-phase trial investigating the preliminary tolerability and proper dosage of the treatment in a group of patients with advanced solid tumors that harbor the FGFR2 and/or FGFR3 gene alterations, according to a press release. “With the…

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Cholangiocarcinoma, or bile duct most cancers, is lethal even when caught early. The 5-year survival rate amongst these identified early is 17% to 25%; for many sufferers, the speed is under 10%. Experts say the important thing to bettering these dismal statistics is to give attention to the various genetic…

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Helsinn Group and BridgeBio Pharma Announce Update to Strategic Collaboration to Develop, Manufacture and Commercialize Infigratinib in Oncology Indications in the U.S.

Lugano, Switzerland and Palo Alto, CA – Helsinn Group (Helsinn), a fully integrated, global biopharma company with a diversified pipeline of innovative oncology assets and strong track-record of commercial execution, and BridgeBio Pharma, Inc. (Nasdaq: BBIO) (BridgeBio), a commercial-stage biopharmaceutical company that focuses on genetic diseases and cancers, announced an…

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Erdafitinib Yields Durable Responses in Advanced Urothelial Carcinoma

Erdafitinib demonstrated durable activity in patients with locally advanced or metastatic urothelial carcinoma with specific FGFR alterations, according to updated results from the BLC2001 trial published in The Lancet Oncology.1 The phase 2 BLC2001 trial (ClinicalTrials.gov Identifier: NCT02365597) was designed to investigate erdafitinib in patients with locally advanced and unresectable…

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FGFR2 accommodates osteogenic cell fate determination in human mesenchymal stem cells

Stem cell-based therapies offer significant potential for treating disease or injury through the regeneration of damaged tissues. Among the various stem cells available, mesenchymal stem cells (MSCs) are garnering considerable interest because of their availability, ease of isolation, and multipotency. Importantly, under appropriate culture conditions, MSCs can be selectively induced…

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Characterization of Blood- Based Molecular Profiling in Pancreatic Adenocarcinoma

Introduction Most cases of pancreatic adenocarcinoma (PDAC) are diagnosed in the metastatic or locally advanced stage. It is the fourth leading cause of cancer death in the United States,1,2 with a 5-year overall survival (OS) around 10% in this country2 despite years of research and therapeutic development. For those patients…

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The Current Molecular Treatment Landscape of Advanced Colorectal Cancer and Need for the COLOMATE Platform

Next-Generation Sequencing Utilizing Tumor Tissue and/or Blood The identification of actionable genomic alterations in tumors such as mCRC was once performed by Sanger DNA sequencing of tumor DNA that was extracted from fixed paraffin-embedded tumor tissue, but this has now been replaced by next-generation sequencing (NGS), which allows for larger-scale…

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Dual Targeting of CDKN2A and PIK3CA May Offer Better Outcomes in Urothelial Carcinoma

Genomic testing varies in the academic and community setting. For community settings, commercial panels are available. However, academic settings have access to tools that provide a more comprehensive views of the genome. Investigators used patient-derived UC organoid (PDO) harboring FGFR3, PIK3CA, and CDKN2A mutations. Dose-response curves of alpelisib (Piqray), abemaciclib…

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