Transitional cell carcinoma

Summary of opinion: Keytruda, 22/02/2024 Positive

Retrieved on: 
Sunday, March 10, 2024
Carboplatin, GEJ, Hodgkin lymphoma, Patient, HNSCC, Cervical cancer, Ageing, CHL, Colorectal cancer, ALK, BTC, Head, Large intestine, Neck, Committee, Recurrence, IIC, Marketing, RCC, Renal cell carcinoma, Cancer, TPS, CHMP, Trastuzumab, TNBC, Paclitaxel, ASCT, Axitinib, Transitional epithelium, NSCLC, Lung cancer, European Commission, EGFR, Cholangiocarcinoma, Medication package insert, CRC, Neoplasm, Radiation, Cisplatin, Civil service commission, Pembrolizumab, Endometrial cancer, Nephrectomy, Platinum, MSI-H, Pemetrexed, Bevacizumab, Risk, Transitional cell carcinoma, CPS, PD-L1

Summary of opinion: Keytruda, 22/02/2024 Positive

Key Points: 


Summary of opinion: Keytruda, 22/02/2024 Positive

First Patient Dosed in Trial Evaluating Efti and the Anti-PD-L1 Therapy BAVENCIO® in Metastatic Urothelial Cancer

Retrieved on: 
Thursday, January 4, 2024
IO, Merck Group, ASX, Autoimmune disease, Immune system, Death, Bladder cancer, Carcinoma, Hope, IMM, PD-L1, Avelumab, Research, Cancer, Transitional cell carcinoma, Patient, Safety, Transitional epithelium

SYDNEY, AUSTRALIA, Jan. 04, 2024 (GLOBE NEWSWIRE) -- Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep” or “the Company”), a clinical-stage biotechnology company developing novel LAG-3 immunotherapies for cancer and autoimmune disease, today announces that the first patient has been enrolled and safely dosed in the INSIGHT-005 Phase I trial. The investigator-initiated study jointly funded with Merck KGaA, Darmstadt, Germany, will evaluate eftilagimod alpha (“efti”) in combination with BAVENCIO® (avelumab) in up to 30 patients with metastatic urothelial carcinoma.

Key Points: 
  • The investigator-initiated study jointly funded with Merck KGaA, Darmstadt, Germany, will evaluate eftilagimod alpha (“efti”) in combination with BAVENCIO® (avelumab) in up to 30 patients with metastatic urothelial carcinoma.
  • Encouragingly, responses were achieved even in cancer patients with low and negative PD-L1 expression, who typically would not be expected to respond to anti-PD-(L)1 therapy.
  • Daniel Pink, as part of the investigator-initiated INSIGHT platform for studies investigating efti in different combination treatments and routes of administration.
  • For 2023, it was estimated there would be 82,290 new cases of bladder cancer and 16,710 deaths in the US alone.1

FDA Grants Priority Review for Supplemental Biologics License Application (sBLA) of PADCEV® (enfortumab vedotin-ejfv) with KEYTRUDA® (pembrolizumab) for First-Line Treatment of Advanced Bladder Cancer

Retrieved on: 
Thursday, November 30, 2023
Science, Biotechnology, Research, Pharmaceutical, Oncology, Health, FDA, Clinical Trials, Cisplatin, Priority review, Safety, Food, Progression-free survival, Breakthrough therapy, Transitional cell carcinoma, Carcinoma, Ureter, Bladder cancer, Patient, PFS, Pembrolizumab, Brentuximab vedotin, PDUFA, Inc., Pharmaceutical industry

Under the Prescription Drug User Fee Act (PDUFA), the FDA has set a target action date of May 9, 2024.

Key Points: 
  • Under the Prescription Drug User Fee Act (PDUFA), the FDA has set a target action date of May 9, 2024.
  • The FDA is reviewing the application under its Real-Time Oncology Review (RTOR) program, which aims to explore a more efficient review process to ensure that safe and effective treatments are available to patients as early as possible.
  • If approved, this combination would be the first treatment option for cisplatin eligible and ineligible patients.
  • In February 2020, PADCEV in combination with KEYTRUDA was granted Breakthrough Therapy designation by the FDA and the EV-103 sBLA received Priority Review designation in December 2022.

FDA Grants Priority Review for Supplemental Biologics License Application (sBLA) of PADCEV® (enfortumab vedotin-ejfv) with KEYTRUDA® (pembrolizumab) for First-Line Treatment of Advanced Bladder Cancer

Retrieved on: 
Thursday, November 30, 2023
Cisplatin, Priority review, Safety, Food, Progression-free survival, Breakthrough therapy, Transitional cell carcinoma, Carcinoma, Ureter, Bladder cancer, Patient, PFS, Astellas Pharma, FDA, Pembrolizumab, Brentuximab vedotin, PDUFA, Pharmaceutical industry

TOKYO and BOTHELL, Wash., Nov. 30, 2023 /PRNewswire/ -- Astellas Pharma Inc. (TSE:4503, President and CEO: Naoki Okamura, "Astellas") and Seagen Inc. (Nasdaq: SGEN) today announced that on November 30, 2023 the U.S. Food and Drug Administration (FDA) accepted for priority review a supplemental Biologics License Application (sBLA) for PADCEV® (enfortumab vedotin-ejfv) with KEYTRUDA® (pembrolizumab) as a combination therapy for the treatment of adult patients with locally advanced or metastatic urothelial cancer (la/mUC), a form of bladder cancer that has spread to surrounding organs or muscles, or other parts of the body.

Key Points: 
  • Under the Prescription Drug User Fee Act (PDUFA), the FDA has set a target action date of May 9, 2024.
  • If approved, this combination would be the first treatment option for cisplatin eligible and ineligible patients.
  • We are committed to delivering on our goal of helping patients with advanced urothelial cancer live longer."
  • "Through our clinical development program, data have consistently shown the impact of combining enfortumab vedotin with pembrolizumab for advanced bladder cancer.

Immutep Receives Approval to Initiate INSIGHT-005 Trial Evaluating Eftilagimod Alpha and Anti-PD-L1 Therapy BAVENCIO®

Retrieved on: 
Monday, May 1, 2023
Carcinoma, MHC, Cancer, Paul Ehrlich Institute, Merck Group, Bladder cancer, ASX, B cell, Cell, Transitional cell carcinoma, IMM, National Cancer Institute, Death, MHC class II, Patient, Autoimmune disease, Research, Vaccine, Eftilagimod alpha, PD-L1, Avelumab, Safety, Transitional epithelium, Pharmaceutical industry, Biomedicine

SYDNEY, AUSTRALIA, May 01, 2023 (GLOBE NEWSWIRE) -- Immutep Limited (ASX: IMM; NASDAQ: IMMP), a clinical-stage biotechnology company developing novel LAG-3 immunotherapies for cancer and autoimmune disease, today announces it has received regulatory approval from the Paul-Ehrlich-Institut (“PEI”), German Federal Institute for Vaccines and Biomedicines, to initiate INSIGHT-005, an investigator-initiated, open-label Phase I trial evaluating the safety and efficacy of eftilagimod alpha (“efti”) in combination with BAVENCIO® (avelumab) in up to 30 patients with metastatic urothelial carcinoma.

Key Points: 
  • Urothelial carcinoma is the most common type of bladder cancer.
  • “We are excited to get this important trial underway.
  • Encouragingly, deep and durable responses were achieved in patients with low or negative PD-L1 expression as well as immuno-oncology insensitive tumours.
  • INSIGHT currently consists of 5 different arms from stratums A to E (INSIGHT-005 is Stratum E).

First patient cells collected in XNK's preclinical bladder cancer study

Retrieved on: 
Thursday, December 15, 2022
Therapy, Squamous cell carcinoma, NK, MD Anderson Cancer Center, Immunotherapy, Transitional epithelium, Bladder cancer, University, Karolinska University Hospital, Patient, Cancer, Multiple myeloma, Radiation, American Cancer Society, Survival rate, World Health Organization, MM, Death, AML, Trial of the century, Acute myeloid leukemia, Transitional cell carcinoma, Pharmaceutical industry

This is the company's first solid tumor indication and complements the ongoing Phase II clinical study in multiple myeloma (MM) and the preclinical proof-of-concept study in acute myeloid leukemia (AML) using patient samples from The University of Texas MD Anderson Cancer Center.

Key Points: 
  • This is the company's first solid tumor indication and complements the ongoing Phase II clinical study in multiple myeloma (MM) and the preclinical proof-of-concept study in acute myeloid leukemia (AML) using patient samples from The University of Texas MD Anderson Cancer Center.
  • Between 10-15 patients with advanced urothelial cancer will be enrolled in the study and will donate cells before and after chemotherapy treatment.
  • More than 80,000 new cases of bladder cancer are expected in the US in 2022 alone, according to the American Cancer Society.
  • It is the 4th most common form of cancer in men and the American Cancer Society estimates that bladder cancer will cause over 17,000 deaths in 2022 in US alone.

First patient cells collected in XNK's preclinical bladder cancer study

Retrieved on: 
Thursday, December 15, 2022
Therapy, Squamous cell carcinoma, NK, MD Anderson Cancer Center, Immunotherapy, Transitional epithelium, Bladder cancer, University, Karolinska University Hospital, Patient, Cancer, Multiple myeloma, Radiation, American Cancer Society, Survival rate, World Health Organization, MM, Death, AML, Trial of the century, Acute myeloid leukemia, Transitional cell carcinoma, Pharmaceutical industry

This is the company's first solid tumor indication and complements the ongoing Phase II clinical study in multiple myeloma (MM) and the preclinical proof-of-concept study in acute myeloid leukemia (AML) using patient samples from The University of Texas MD Anderson Cancer Center.

Key Points: 
  • This is the company's first solid tumor indication and complements the ongoing Phase II clinical study in multiple myeloma (MM) and the preclinical proof-of-concept study in acute myeloid leukemia (AML) using patient samples from The University of Texas MD Anderson Cancer Center.
  • Between 10-15 patients with advanced urothelial cancer will be enrolled in the study and will donate cells before and after chemotherapy treatment.
  • More than 80,000 new cases of bladder cancer are expected in the US in 2022 alone, according to the American Cancer Society.
  • It is the 4th most common form of cancer in men and the American Cancer Society estimates that bladder cancer will cause over 17,000 deaths in 2022 in US alone.

Immutep Enters into Second Clinical Trial Collaboration Agreement with Merck KGaA, Darmstadt, Germany, and Pfizer for New Combination Study of its First-in-Class LAG-3 Candidate, Eftilagimod Alpha, and Avelumab to Treat Urothelial Cancer

Retrieved on: 
Tuesday, November 29, 2022
Autoimmune disease, INSIGHT, MHC, Immutep, Fast track (FDA), Head, Clinical trial, IKF, APC, MHC II, CD8, NSCLC, LAG-3, RECIST, Squamous cell carcinoma, Antibody, Cell, Merck Group, Safety, Large-cell lung carcinoma, ASX, Patient, Monocyte, Transitional epithelium, Immunology, FDA, Transitional cell carcinoma, HNSCC, Avelumab, NK, Ethics, Time-invariant system, Cancer, Agreement, B cell, PD-L1, Bladder cancer, Immunotherapy, IMM, CXCL10, Pharmaceutical industry, Vaccine, Pfizer

The first patient is expected to be enrolled and dosed in H1 of calendar year 2023, after completing the necessary ethics and regulatory steps.

Key Points: 
  • The first patient is expected to be enrolled and dosed in H1 of calendar year 2023, after completing the necessary ethics and regulatory steps.
  • Urothelial cancer is a type of cancer in the bladder or urinary tract.
  • Under the Agreement, Immutep and Merck KGaA, Darmstadt, Germany will jointly fund the INSIGHT-005 study.
  • Additional LAG-3 product candidates, including antibodies for immune response modulation, are licensed to and being developed by Immuteps large pharmaceutical partners.

UroGen Pharma Reports Third Quarter 2022 Financial Results and Recent Corporate Developments

Retrieved on: 
Thursday, November 10, 2022
Medical Devices, Medical Supplies, Hospitals, Clinical Trials, Other Health, Biotechnology, General Health, Pharmaceutical, Health, Oncology, Adult, Clothing, Risk, Transitional epithelium, Patient Information Advisory Group, Stomach, Company, Pharmakon—Danish College of Pharmacy Practice, Kidney, Recurrence, Blood, Ureter, Swelling, Birth, Urination, Urinary tract infection, SEC, NMIBC, Water, Time, Cancer, Orphan drug, Neoplasm, Patient, UTUC, Urine, COVID-19, Vomiting, Private Securities Litigation Reform Act, Sodium bicarbonate, Bone marrow, Medicine, Clinical trial, Breast milk, Fatigue, Skin, Growth, Abdomen, Nausea, Perforation, NDA, FDA, Trial of the century, Urinary bladder, Fever, Technology, View, Man, Safety, Female, Pain, Transitional cell carcinoma, Nephrectomy, Pharmaceutical industry, Medical imaging, Health insurance, Birth control, Tanning (leather), Phosphorus, Generic drug, Mitomycins, Mitomycin C

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.
  • You should not receive JELMYTO if you have a hole or tear (perforation) of your bladder or upper urinary tract.
  • Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with JELMYTO.
  • JELMYTO and UroGen are registered trademarks of UroGen Pharma Ltd.
    View source version on businesswire.com: https://www.businesswire.com/news/home/20221110005284/en/

UroGen Pharma Reports Second Quarter 2022 Financial Results and Recent Corporate Developments

Retrieved on: 
Thursday, August 11, 2022
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Nausea, Trial of the century, Female, SEC, Cancer, Clinical trial, Urine, Pain, Blood, Fever, Patient, Swelling, Skin, Clothing, Sodium bicarbonate, Perforation, Breast milk, Disease, Risk, NDA, Technology, Private Securities Litigation Reform Act, UTUC, Patient Information Advisory Group, Recurrence, Ureter, Safety, Water, Birth, Growth, Neoplasm, Man, Fatigue, NMIBC, Bladder cancer, Bone marrow, COVID-19, Stomach, Urinary bladder, Urination, Kidney, Time, Orphan drug, Transitional cell carcinoma, FDA, Vomiting, Abdomen, Nephrectomy, Company, Twitter, View, TURBT, Urinary tract infection, Transitional epithelium, Medicine, Adult, Pharmaceutical industry, Medical imaging, Health insurance, Birth control, Tanning (leather), Phosphorus, Generic drug, Pharmakon—Danish College of Pharmacy Practice, Mitomycin C, Mitomycins

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.
  • You should not receive JELMYTO if you have a hole or tear (perforation) of your bladder or upper urinary tract.
  • Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with JELMYTO.
  • UroGen are registered trademarks of UroGen Pharma Ltd.
    View source version on businesswire.com: https://www.businesswire.com/news/home/20220811005112/en/