Transitional epithelium

LabCorp Announces Availability of New QIAGEN therascreen FGFR mutation analysis companion diagnostic for Bladder Cancer

Retrieved on: 
Friday, May 10, 2019

Since 2018, the Company collaborated with more than 75 clients on over 150 projects targeted at the development of new companion diagnostic tests.

Key Points: 
  • Since 2018, the Company collaborated with more than 75 clients on over 150 projects targeted at the development of new companion diagnostic tests.
  • LabCorp is committed to bringing precision testing to patients as quickly as possible, said Marcia Eisenberg, PhD, chief scientific officer, LabCorp Diagnostics.
  • LabCorp offers end-to-end support for diagnostic development and accelerated commercialization, distinctly positioning us at the intersection of research and patient care.
  • Urothelial cancer, or transitional cell carcinoma (TCC), is the most prevalent form of bladder cancer, which constitutes the sixth most common type of cancer in the U.S.

QIAGEN Launches First FDA-Approved Companion Diagnostic Using FGFR Alterations to Help Guide the Treatment of Metastatic Urothelial Cancer

Retrieved on: 
Friday, April 12, 2019

Urothelial cancer begins in tissues lining the bladder and other genitourinary organs and is the sixth most common type of cancer in the United States.

Key Points: 
  • Urothelial cancer begins in tissues lining the bladder and other genitourinary organs and is the sixth most common type of cancer in the United States.
  • A percentage of urothelial carcinoma tumors have certain FGFR alterations which are thought to be key drivers of tumor growth.
  • Detection of these alterations utilizing the companion diagnostic will help identify patients eligible for treatment with BALVERSA.
  • The therascreen FGFR Kit co-approval with BALVERSA marks the sixth FDA approval of a therapy with a QIAGEN companion diagnostic assay.

Astex Pharmaceuticals Celebrates as Second New Cancer Drug Receives US Marketing Approval

Retrieved on: 
Friday, April 12, 2019

Under the ongoing collaboration, Janssen isresponsible for the clinical development and commercialisation of all products, including erdafitinib.

Key Points: 
  • Under the ongoing collaboration, Janssen isresponsible for the clinical development and commercialisation of all products, including erdafitinib.
  • Urothelial cancer, particularly of the bladder, is the sixth most common type of cancer in the USA.
  • Astex is a leader in innovative drug discovery anddevelopment, committed to the fight against cancer and diseases of the central nervous system.
  • Otsuka Pharmaceutical is a global healthcare company with the corporate philosophy: Otsuka people creating new products for better health worldwide.

BALVERSA™ (erdafitinib) Receives U.S. FDA Approval for the Treatment of Patients with Locally Advanced or Metastatic Urothelial Carcinoma with Certain FGFR Genetic Alterations

Retrieved on: 
Friday, April 12, 2019

"BALVERSA is an important new therapy for this small subset of patients with urothelial carcinoma who, up until now, had limited treatment options."

Key Points: 
  • "BALVERSA is an important new therapy for this small subset of patients with urothelial carcinoma who, up until now, had limited treatment options."
  • Information on FDA-approved tests for the detection of FGFR genetic alterations in urothelial carcinoma is available at: http://www.fda.gov/CompanionDiagnostics .
  • This model is part of Janssen'songoing commitment to provide high-quality products, services, access, and support to healthcare professionals and patients.
  • Dry eye symptoms occurred in 28% of patients during treatment with BALVERSA and were Grade 3 in 6% of patients.

FDA approves first targeted therapy for metastatic bladder cancer

Retrieved on: 
Friday, April 12, 2019

Bladder cancers are associated with genetic mutations that are present in the patient's bladder or entire urothelium (the lining of the lower urinary tract).

Key Points: 
  • Bladder cancers are associated with genetic mutations that are present in the patient's bladder or entire urothelium (the lining of the lower urinary tract).
  • Bladder cancer is the sixth most common cancer in the United States.
  • Fibroblast growth factor (FGFR) alterations are present in approximately one in five patients with recurrent and refractory bladder cancer.
  • About a quarter of patients in the study were previously treated with anti PD-L1/PD-1 therapy, which is a standard treatment for patients with locally advanced or metastatic bladder cancer.

UroGen Pharma Announces Presentation of Analysis from Phase 3 OLYMPUS Trial of UGN-101 for Patients with Low-Grade Upper Tract Urothelial Cancer

Retrieved on: 
Friday, April 5, 2019

UroGen is committed to raising the standard of care for this typically elderly patient population whose current options consist of repetitive endoscopic surgical intervention or complete loss of a kidney.

Key Points: 
  • UroGen is committed to raising the standard of care for this typically elderly patient population whose current options consist of repetitive endoscopic surgical intervention or complete loss of a kidney.
  • We look forward to presenting this UGN-101 analysis that further underscores the unmet need in patients with new and recurrent LG UTUC.
  • UGN-101 (mitomycin gel) for instillation is an investigational drug formulation of mitomycin in Phase 3 development for the treatment of low-grade upper tract urothelial cancer (LG UTUC).
  • UroGen has developed RTGel, a proprietary sustained release, hydrogel-based platform technology that has the potential to improve therapeutic profiles of existing drugs.

Nektar Therapeutics to Webcast Conference Call with Urothelial Cancer Specialist for Analysts & Investors at the 2019 ASCO Genitourinary Cancers Symposium

Retrieved on: 
Monday, February 11, 2019

Analyst Call with Urothelial Cancer Specialist:

Key Points: 
  • Analyst Call with Urothelial Cancer Specialist:
    The conference call will include PIVOT-02 investigator Arlene O. Siefker-Radtke, M.D., Professor, Department of Genitourinary Medical Oncology, Division of Cancer Medicine at The University of Texas MD Anderson Cancer Center and Clinical Co-leader of the Bladder Cancer SPORE Executive Committee.
  • The webcast and slides for the conference call can be accessed through a link that is posted on the Investors section of the Nektar website at https://ir.nektar.com/events-and-presentations/events .
  • The web broadcast of the conference call will be available for replay through March 15, 2019.
  • Nektar is headquartered in San Francisco, California, with additional operations in Huntsville, Alabama and Hyderabad, India.