Transitional cell carcinoma

Seagen and Astellas Announce U.S. FDA Acceptance of Two Supplemental Biologics License Applications for PADCEV® (enfortumab vedotin-ejfv) in Locally Advanced or Metastatic Urothelial Cancer

Retrieved on: 
Monday, April 19, 2021
Science, Biotechnology, Research, Pharmaceutical, Oncology, Health, FDA, Clinical trials, Cancer treatments, Clinical medicine, Cancer immunotherapy, Medicine, Breakthrough therapy, Monoclonal antibodies, Enfortumab vedotin, PD-1 and PD-L1 inhibitors, Transitional cell carcinoma, PD-L1, Peripheral neuropathy, the EV-301 Trial, the EV-201 Trial, Astellas, Seagen, the Astellas and Seagen Collaboration, THE EV-301 TRIAL, THE EV-201 TRIAL, ASTELLAS, SEAGEN, THE ASTELLAS AND SEAGEN COLLABORATION

In one clinical trial, the median time to onset of severe skin reactions was 0.8 months (range: 0.2 to 5.3).

Key Points: 
  • In one clinical trial, the median time to onset of severe skin reactions was 0.8 months (range: 0.2 to 5.3).
  • Withhold PADCEV and consider referral for specialized care for severe (Grade 3) skin reactions, suspected SJS, or TEN.
  • Permanently discontinue PADCEV in patients that develop Grade \xe2\x89\xa53 peripheral neuropathy.\nOcular disorders occurred in 46% of the 310 patients treated with PADCEV.
  • EV-201 Cohort 2: Enfortumab vedotin in cisplatin-ineligible patients with locally advanced or metastatic urothelial cancer who received prior PD-1/PD-L1 inhibitors [abstract].

Resistance to Immunotherapy in Patients with Urothelial Bladder Cancer Is Traced to Specific Sets of Immune Cells

Retrieved on: 
Friday, April 9, 2021
Clinical medicine, Medicine, Cancer immunotherapy, Cancer, Immune system, Immunotherapy, Virotherapy, Checkpoint inhibitor, Bladder cancer, Tumor microenvironment, Transitional cell carcinoma, Immune checkpoint

NEW YORK, April 9, 2021 /PRNewswire-PRWeb/ -- Sets of genes associated with resistance to immunotherapy in patients with metastatic urothelial cancer of the bladder have been identified and validated by researchers at Mount Sinai.

Key Points: 
  • NEW YORK, April 9, 2021 /PRNewswire-PRWeb/ -- Sets of genes associated with resistance to immunotherapy in patients with metastatic urothelial cancer of the bladder have been identified and validated by researchers at Mount Sinai.
  • The researchers then identified specific cells in the tumor microenvironment associated with resistance to immune checkpoint blockade, and potential targets for therapies designed to overcome resistance.
  • The research is among the first to use both bulk and single-cell RNA sequencing of human bladder tumors to study resistance to immunotherapy.
  • "Our research shows that a specific cellular state of myeloid cells underlying pro-tumorigenic inflammation account for resistance to immune checkpoint blockade in a very large percentage of patients with urothelial bladder cancer," Dr. Galsky says.

Merck Receives Positive EU CHMP Opinion for Updated Label of KEYTRUDA® (pembrolizumab) To Include Results of Phase 3 KEYNOTE-361 Trial in Certain Adult Patients with Locally Advanced or Metastatic Urothelial Cancer

Retrieved on: 
Tuesday, March 30, 2021
Biotechnology, Health, Pharmaceutical, Clinical trials, Oncology, Cancer treatments, Clinical medicine, Drugs, Breakthrough therapy, Orphan drugs, Cancer immunotherapy, Antineoplastic drugs, Pembrolizumab, Merkel-cell carcinoma, Transitional cell carcinoma, Transitional epithelium, Avelumab

KEYTRUDA is indicated for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC).

Key Points: 
  • KEYTRUDA is indicated for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC).
  • Of the patients who developed pneumonitis, 42% of these patients interrupted KEYTRUDA, 68% discontinued KEYTRUDA, and 77% had resolution.
  • In KEYNOTE-052, KEYTRUDA was discontinued due to adverse reactions in 11% of 370 patients with locally advanced or metastatic urothelial carcinoma.
  • In KEYNOTE-045, KEYTRUDA was discontinued due to adverse reactions in 8% of 266 patients with locally advanced or metastatic urothelial carcinoma.

FDA Approves Merck’s KEYTRUDA® (pembrolizumab) Plus Platinum- and Fluoropyrimidine-Based Chemotherapy for Treatment of Certain Patients With Locally Advanced or Metastatic Esophageal or Gastroesophageal Junction (GEJ) Carcinoma

Retrieved on: 
Tuesday, March 23, 2021
Oncology, FDA, Health, Clinical trials, Pharmaceutical, Biotechnology, Drugs, Clinical medicine, Cancer treatments, Orphan drugs, Breakthrough therapy, Antineoplastic drugs, Monoclonal antibodies, Carcinoma, Pembrolizumab, Merkel-cell carcinoma, Sorafenib, Transitional cell carcinoma, Esophageal Cancer, the Merck Access Program for KEYTRUDA, Merck’s Patient Support Program for KEYTRUDA, Merck

KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

Key Points: 
  • KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.
  • KEYTRUDA is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib.
  • KEYTRUDA is indicated for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC).
  • KEYTRUDA is indicated for the treatment of patients with recurrent or metastatic cutaneous squamous cell carcinoma (cSCC) that is not curable by surgery or radiation.

Genentech Provides Update on Tecentriq U.S. Indication in Prior-Platinum Treated Metastatic Bladder Cancer

Retrieved on: 
Monday, March 8, 2021
Research, Hospitals, FDA, Genetics, Clinical trials, Biotechnology, Pharmaceutical, Health, Science, Oncology, Health sciences, Life sciences, Drugs, Breakthrough therapy, Orphan drugs, Carcinoma, Atezolizumab, Genentech, Transitional cell carcinoma, Transitional epithelium, Bladder cancer, MUC, Tecentriq (atezolizumab), Genentech in cancer immunotherapy, Genentech

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the company is voluntarily withdrawing the U.S. indication for Tecentriq (atezolizumab) in prior-platinum treated metastatic urothelial carcinoma (mUC, bladder cancer).

Key Points: 
  • Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the company is voluntarily withdrawing the U.S. indication for Tecentriq (atezolizumab) in prior-platinum treated metastatic urothelial carcinoma (mUC, bladder cancer).
  • Patients being treated with Tecentriq for prior-platinum treated mUC should discuss their care with their healthcare provider.
  • While the withdrawal of Tecentriq for prior-platinum treated bladder cancer is disappointing, Tecentriq continues to demonstrate benefits across multiple cancer types and therefore remains a meaningful treatment option for many patients."
  • Tecentriq is a prescription medicine used to treat adults with:
    A type of bladder and urinary tract cancer called urothelial carcinoma.

Global Advanced Urotheilal carcinoma Pipeline Insight Report 2021 Featuring Rogaratininb (Bayer) & Sitravatinib (Mirati Therapeutics) - ResearchAndMarkets.com

Retrieved on: 
Tuesday, February 23, 2021
Health, Oncology, Carcinoma, Transitional cell carcinoma, Transitional epithelium, Drug pipeline, Pipeline, Orphan drugs, Branches of biology, Drugs, Health, Breakthrough therapy

The "Advanced Urotheilal carcinoma - Pipeline Insight, 2021" drug pipelines has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Advanced Urotheilal carcinoma - Pipeline Insight, 2021" drug pipelines has been added to ResearchAndMarkets.com's offering.
  • This "Advanced Urothelial Carcinoma - Pipeline Insight, 2021," report provides comprehensive insights about 10+ companies and 10+ pipeline drugs in Advanced Urothelial Carcinoma pipeline landscape.
  • The companies and academics are working to assess challenges and seek opportunities that could influence Advanced Urothelial Carcinoma R&D.
  • Advanced Urothelial Carcinoma pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration.

Astellas and Seagen Announce Submission of Two Supplemental Biologics License Applications to the U.S. FDA for PADCEV® (enfortumab vedotin-ejfv) in Locally Advanced or Metastatic Urothelial Cancer

Retrieved on: 
Thursday, February 18, 2021
Cancer treatments, Clinical medicine, Cancer immunotherapy, Medicine, Breakthrough therapy, Monoclonal antibodies, Orphan drugs, Enfortumab vedotin, Transitional cell carcinoma, Bladder cancer, PD-1 and PD-L1 inhibitors, Transitional epithelium

"Locally advanced or metastatic urothelial cancer is an aggressive disease with limited treatment options."

Key Points: 
  • "Locally advanced or metastatic urothelial cancer is an aggressive disease with limited treatment options."
  • [2]
    "Advanced bladder cancer patients urgently need more treatment options," said Roger Dansey, M.D., Chief Medical Officer, Seagen.
  • "Based on recently presented clinical trial results, PADCEV could address a significant unmet need for more patients with advanced urothelial cancer after initial immunotherapy treatment."
  • EV-201 Cohort 2: Enfortumab vedotin in cisplatin-ineligible patients with locally advanced or metastatic urothelial cancer who received prior PD-1/PD-L1 inhibitors.

Seagen and Astellas Announce Submission of Two Supplemental Biologics License Applications to the U.S. FDA for PADCEV® (enfortumab vedotin-ejfv) in Locally Advanced or Metastatic Urothelial Cancer

Retrieved on: 
Thursday, February 18, 2021
Oncology, Health, Clinical trials, Research, Science, Pharmaceutical, Biotechnology, Cancer treatments, Clinical medicine, Medicine, Cancer immunotherapy, Breakthrough therapy, Monoclonal antibodies, Orphan drugs, Enfortumab vedotin, Transitional cell carcinoma, PD-1 and PD-L1 inhibitors, Transitional epithelium, PD-L1, the EV-301 Trial, the EV-201 Trial, Urothelial Cancer, PADCEV® (enfortumab vedotin-ejfv), Seagen, Astellas, the Seagen and Astellas Collaboration

Locally advanced or metastatic urothelial cancer is an aggressive disease with limited treatment options.

Key Points: 
  • Locally advanced or metastatic urothelial cancer is an aggressive disease with limited treatment options.
  • Based on recently presented clinical trial results, PADCEV could address a significant unmet need for more patients with advanced urothelial cancer after initial immunotherapy treatment.
  • Hyperglycemia occurred in patients treated with PADCEV, including death and diabetic ketoacidosis (DKA), in those with and without pre-existing diabetes mellitus.
  • EV-201 Cohort 2: Enfortumab vedotin in cisplatin-ineligible patients with locally advanced or metastatic urothelial cancer who received prior PD-1/PD-L1 inhibitors.

Astellas and Seagen Announce Presentation of Results from PADCEV® (enfortumab vedotin-ejfv) Pivotal Trial in Patients with Previously Treated Advanced Urothelial Cancer Who Were Ineligible for Cisplatin Chemotherapy

Retrieved on: 
Friday, February 12, 2021
Clinical medicine, Organ systems, Medicine, Breakthrough therapy, Cancer immunotherapy, Peripheral neuropathy, Enfortumab vedotin, Diabetes, Hyperglycemia, Transitional cell carcinoma, Complications of diabetes, Book:Diabetes mellitus type 1

Cohort 2 of the EV-201 trial evaluated PADCEV in patients with locally advanced or metastatic urothelial cancer who had been previously treated with a PD-1/L1 inhibitor, had not received a platinum-containing chemotherapy in this setting, and were ineligible for cisplatin.

Key Points: 
  • Cohort 2 of the EV-201 trial evaluated PADCEV in patients with locally advanced or metastatic urothelial cancer who had been previously treated with a PD-1/L1 inhibitor, had not received a platinum-containing chemotherapy in this setting, and were ineligible for cisplatin.
  • The trial enrolled 128 patients in cohort 1 and 91 patients in cohort 2 at multiple centers internationally.
  • Hyperglycemia occurred in patients treated with PADCEV, including death and diabetic ketoacidosis (DKA), in those with and without pre-existing diabetes mellitus.
  • In one clinical trial, peripheral neuropathy occurred in patients treated with PADCEV with or without preexisting peripheral neuropathy.

Seagen and Astellas Announce Presentation of Results from PADCEV® (enfortumab vedotin-ejfv) Pivotal Trial in Patients with Previously Treated Advanced Urothelial Cancer Who Were Ineligible for Cisplatin Chemotherapy

Retrieved on: 
Friday, February 12, 2021
Oncology, Health, Clinical trials, Research, Science, Pharmaceutical, Biotechnology, Clinical medicine, Medicine, Health sciences, Breakthrough therapy, Cancer immunotherapy, Orphan drugs, Monoclonal antibodies, Enfortumab vedotin, Transitional cell carcinoma, Diabetes, Diabetic ketoacidosis, Hyperglycemia

Twenty percent of patients had a complete response, the absence of detectable cancer, after PADCEV treatment, and 31 percent had a partial response.

Key Points: 
  • Twenty percent of patients had a complete response, the absence of detectable cancer, after PADCEV treatment, and 31 percent had a partial response.
  • Cohort 2 of the EV-201 trial evaluated PADCEV in patients with locally advanced or metastatic urothelial cancer who had been previously treated with a PD-1/L1 inhibitor, had not received a platinum-containing chemotherapy in this setting, and were ineligible for cisplatin.
  • The trial enrolled 128 patients in cohort 1 and 91 patients in cohort 2 at multiple centers internationally.
  • Hyperglycemia occurred in patients treated with PADCEV, including death and diabetic ketoacidosis (DKA), in those with and without pre-existing diabetes mellitus.