Transitional cell carcinoma

UroGen Pharma Reports First Quarter 2020 Financial Results and Recent Corporate Developments

Retrieved on: 
Thursday, May 7, 2020
Oncology, Health, FDA, Other Health, Clinical trials, Pharmaceutical, Biotechnology, Health, Articles, Life sciences, Fast track, Orphan drug, Breakthrough therapy, Transitional cell carcinoma, Food and Drug Administration, the Phase 3 OLYMPUS Trial, JelmytoTM, Upper Tract Urothelial Cancer (UTUC)

The U.S. FDA previously granted Orphan Drug, Fast Track, and Breakthrough Therapy Designations to Jelmyto for the treatment of LG-UTUC.

Key Points: 
  • The U.S. FDA previously granted Orphan Drug, Fast Track, and Breakthrough Therapy Designations to Jelmyto for the treatment of LG-UTUC.
  • On April 15, 2020, the FDA approved Jelmyto, making it the first drug approved for the treatment of LG-UTUC in adult patients.
  • Urothelial cancer is the ninth most common cancer globally and the eighth most lethal neoplasm in men in the U.S.
  • Our primary focus is on the health and well-being of patients, caregivers, and UroGen employees at this critical juncture.

New Data at the ASCO20 Virtual Scientific Program Reflects Genentech’s Commitment to Accelerating Progress in Cancer Care

Retrieved on: 
Thursday, May 7, 2020
Oncology, Health, Clinical trials, Pharmaceutical, Cardiology, Optical, Biotechnology, Medical specialties, Medicine, Immunology, Atezolizumab, Genentech, Immune system, PD-L1, Programmed cell death protein 1, Transitional cell carcinoma, Transitional epithelium, B7, Cancer immunotherapy, Tecentriq (atezolizumab), Alecensa (alectinib), Genentech in Personalized Healthcare, Genentech

Tecentriq is designed to bind to PD-L1 expressed on tumor cells and tumor-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors.

Key Points: 
  • Tecentriq is designed to bind to PD-L1 expressed on tumor cells and tumor-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors.
  • Tecentriq is a prescription medicine used to treat adults with:
    A type of bladder and urinary tract cancer called urothelial carcinoma.
  • The approval of Tecentriq in these patients is based on a study that measured response rate and duration of response.
  • Continued approval for this use may depend on the results of an ongoing study to confirm benefit.

Seattle Genetics to Present at the BofA Securities Virtual Health Care Conference 2020

Retrieved on: 
Tuesday, May 5, 2020
Science, Biotechnology, Research, Pharmaceutical, Oncology, Health, Genetics, Clinical trials, Medical specialties, Seattle Genetics, Takeda Pharmaceutical Company, Monoclonal antibodies, CD30, Branches of biology, Brentuximab vedotin, Life sciences, Lymphoma, Transitional cell carcinoma, Transitional epithelium, Biotechnology

Seattle Genetics, Inc. (Nasdaq:SGEN) announced today that management will participate in a fireside chat during the BofA Securities Virtual Health Care Conference 2020 on Tuesday, May 12, 2020 at 11:40 a.m. Eastern Time.

Key Points: 
  • Seattle Genetics, Inc. (Nasdaq:SGEN) announced today that management will participate in a fireside chat during the BofA Securities Virtual Health Care Conference 2020 on Tuesday, May 12, 2020 at 11:40 a.m. Eastern Time.
  • The presentation will be webcast live and available for replay from Seattle Genetics website at www.seattlegenetics.com in the Investors section.
  • Seattle Genetics, Inc. is a global biotechnology company that discovers, develops and commercializes transformative cancer medicines to make a meaningful difference in peoples lives.
  • ADCETRIS is approved in certain CD30-expressing lymphomas, and PADCEV is approved in certain metastatic urothelial cancers.

The Lancet Oncology Publishes Details of UroGen Pharma’s Pivotal OLYMPUS Trial

Retrieved on: 
Thursday, April 30, 2020
Pharmaceutical, Health, Oncology, Clinical trials, Carcinoma, Transitional cell carcinoma, Transitional epithelium, Kidney, the Phase 3 OLYMPUS Trial, Jelmyto, Upper Tract Urothelial Cancer (UTUC), UroGen Pharma Ltd.

In the pivotal OLYMPUS trial, participants received six once-weekly instillations of Jelmyto via retrograde catheter in the renal pelvis and calyces.

Key Points: 
  • In the pivotal OLYMPUS trial, participants received six once-weekly instillations of Jelmyto via retrograde catheter in the renal pelvis and calyces.
  • As reported in The Lancet Oncology publication, in the trial, 67 patients (94%) experienced adverse events (AEs) and 60 patients (85%) had AEs that were considered to be related to the study treatment or procedure.
  • Primary chemoablation of low-grade upper tract urothelial carcinoma using UGN-101, a mitomycin-containing reverse thermal gel (OLYMPUS): a prospective single-arm phase 3 trial.
  • The Lancet Oncology, 2020
    Browne BM, Stensland KD, Moynihan MJ, Canes D. An Analysis of Staging and Treatment Trends for Upper Tract Urothelial Carcinoma in the National Cancer Database.

Urothelial Carcinoma Pipeline Insights, 2020: Therapeutics, Products, Companies - ResearchAndMarkets.com

Retrieved on: 
Tuesday, April 21, 2020
Health, Pharmaceutical, Neoplasms, Transitional epithelium, Transitional cell carcinoma, Branches of biology, Neprilysin, Carcinoma, Cancer

Urothelial Carcinoma Pipeline Insight, 2020 outlays comprehensive insights of present clinical development scenario and growth prospects across the Urothelial Carcinoma market.

Key Points: 
  • Urothelial Carcinoma Pipeline Insight, 2020 outlays comprehensive insights of present clinical development scenario and growth prospects across the Urothelial Carcinoma market.
  • A detailed picture of the Urothelial Carcinoma pipeline landscape is provided, which includes the disease overview and Urothelial Carcinoma treatment guidelines.
  • The assessment part of the report embraces in-depth Urothelial Carcinoma commercial assessment and clinical assessment of the Urothelial Carcinoma pipeline products from the pre-clinical developmental phase to the marketed phase.
  • How many Urothelial Carcinoma emerging therapies are in early-stage, mid-stage, and late stage of development for the treatment of Urothelial Carcinoma?

Transitional Cell Carcinoma: Global Pipeline Landscape Insights, 2020 - ResearchAndMarkets.com

Retrieved on: 
Tuesday, April 21, 2020
Health, Pharmaceutical, Neoplasms, Carcinoma, Transitional cell carcinoma, Lung cancer, Epithelium, Ovarian cancer

Transitional Cell Carcinoma Pipeline Insight, 2020 outlays comprehensive insights of present clinical development scenario and growth prospects across the Transitional Cell Carcinoma market.

Key Points: 
  • Transitional Cell Carcinoma Pipeline Insight, 2020 outlays comprehensive insights of present clinical development scenario and growth prospects across the Transitional Cell Carcinoma market.
  • A detailed picture of the Transitional Cell Carcinoma pipeline landscape is provided, which includes the disease overview and Transitional Cell Carcinoma treatment guidelines.
  • The assessment part of the report embraces in-depth Transitional Cell Carcinoma commercial assessment and clinical assessment of the Transitional Cell Carcinoma pipeline products from the pre-clinical developmental phase to the marketed phase.
  • How many Transitional Cell Carcinoma emerging therapies are in early-stage, mid-stage, and late stage of development for the treatment of Transitional Cell Carcinoma?

UroGen Pharma Receives U.S. FDA Expedited Approval for Jelmyto™, the First and Only Non-Surgical Treatment for Patients with Low-Grade Upper Tract Urothelial Cancer

Retrieved on: 
Wednesday, April 15, 2020
Oncology, FDA, Health, Clinical trials, Pharmaceutical, Biotechnology, Medical specialties, Carcinoma, Transitional cell carcinoma, Anatomy, Urology, Transitional epithelium, Ureter, Urinary system, Urinary tract infection, Papillary urothelial neoplasm of low malignant potential, the Phase 3 OLYMPUS Trial, Jelmyto™ (mitomycin) for pyelocalyceal solution, Upper Tract Urothelial Cancer (UTUC), UroGen Pharma Ltd.

LG UTUC is a rare cancer that develops in the lining of the upper urinary tract, ureters and kidneys.

Key Points: 
  • LG UTUC is a rare cancer that develops in the lining of the upper urinary tract, ureters and kidneys.
  • These programs are for eligible patients who have been prescribed Jelmyto and who need help managing the cost of treatment.
  • Jelmyto (mitomycin) for pyelocalyceal solution is a drug formulation of mitomycin for the treatment of low-grade upper tract urothelial cancer (LG UTUC).
  • Browne BM, Stensland KD, Moynihan MJ, Canes D. An Analysis of Staging and Treatment Trends for Upper Tract Urothelial Carcinoma in the National Cancer Database.

FDA Approves First Therapy for Treatment of Low-Grade Upper Tract Urothelial Cancer

Retrieved on: 
Wednesday, April 15, 2020
Anatomy, Carcinoma, Transitional cell carcinoma, Organ systems, Animal anatomy, Transitional epithelium, Aging-associated diseases, RTT, Kidney, Ureter, Cancer, Urinary system

SILVER SPRING, Md., April 15, 2020 /PRNewswire/ -- Today, the U.S. Food and Drug Administration approved Jelmyto (mitomycin gel), the first therapy to treat low-grade upper tract urothelial cancer (UTUC).

Key Points: 
  • SILVER SPRING, Md., April 15, 2020 /PRNewswire/ -- Today, the U.S. Food and Drug Administration approved Jelmyto (mitomycin gel), the first therapy to treat low-grade upper tract urothelial cancer (UTUC).
  • Urothelial cancer is a cancer of the lining of the urinary system.
  • Our staff is continuing to meet virtually with drug developers, academic investigators and patient advocates to push forward the coordinated review of drugs, biologics and devices for cancer."
  • UTUC can block the ureter or kidney, causing swelling, infections and impairment of kidney function in some patients.

Seattle Genetics Announces Potential Accelerated Approval Pathway in the U.S. for PADCEV™ (enfortumab vedotin-ejfv) in Combination with Immune Therapy Pembrolizumab as First-Line Treatment for Advanced Urothelial Cancer

Retrieved on: 
Thursday, April 2, 2020
Science, Biotechnology, Research, Pharmaceutical, Oncology, Health, Genetics, Clinical trials, Clinical medicine, Medicine, Cancer, RTT, Antineoplastic drugs, Diabetes, Cancer treatments, Carcinoma, Transitional cell carcinoma, Pembrolizumab, Ketoacidosis, Hyperglycemia, Bladder and Urothelial Cancer, PADCEV, Seattle Genetics, the Astellas and Seattle Genetics Collaboration, the Seattle Genetics, Astellas and Merck Collaboration

Our initial data on the combination of PADCEV and pembrolizumab in previously untreated patients who could not receive cisplatin are encouraging.

Key Points: 
  • Our initial data on the combination of PADCEV and pembrolizumab in previously untreated patients who could not receive cisplatin are encouraging.
  • The EV-302 trial is evaluating the combination of PADCEV and pembrolizumab with or without chemotherapy versus chemotherapy alone in patients with previously untreated locally advanced or metastatic urothelial cancer.
  • PADCEV was approved under the FDAs Accelerated Approval Program based on tumor response rate.
  • Hyperglycemia occurred in patients treated with PADCEV, including death and diabetic ketoacidosis (DKA), in those with and without pre-existing diabetes mellitus.

Infinity Receives Fast Track Designation for IPI-549 in Combination with the Checkpoint Inhibitor Opdivo for the Treatment of Advanced Urothelial Cancer

Retrieved on: 
Wednesday, March 25, 2020
Oncology, FDA, Health, Clinical trials, Pharmaceutical, Biotechnology, Drugs, Clinical medicine, Monoclonal antibodies, Antineoplastic drugs, Breakthrough therapy, Medicine, Bristol-Myers Squibb, Carcinoma, Nivolumab, Transitional cell carcinoma, Transitional epithelium, Pembrolizumab

(NASDAQ: INFI) announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for IPI-549 in combination with nivolumab (Opdivo) for the treatment of advanced urothelial cancer.

Key Points: 
  • (NASDAQ: INFI) announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for IPI-549 in combination with nivolumab (Opdivo) for the treatment of advanced urothelial cancer.
  • The study will enroll approximately 160 checkpoint-nave, advanced urothelial cancer patients who have progressed or recurred following treatment with platinum-based chemotherapy.
  • Patients will be randomized 2:1 to receive IPI-549 administered in combination with Opdivo compared to Opdivo monotherapy plus placebo.
  • MARIO-275 is a global, randomized, controlled combination study of IPI-549 combined with Opdivo in I/O nave urothelial cancer.