Bladder cancer

U.S. FDA Grants Accelerated Approval to Trodelvy® for the Treatment of Metastatic Urothelial Cancer

Tuesday, April 13, 2021 - 10:42pm

The accelerated approval was based on data from the international Phase 2, single-arm TROPHY study.

Key Points: 
  • The accelerated approval was based on data from the international Phase 2, single-arm TROPHY study.
  • An estimated 83,000 Americans will be diagnosed with bladder cancer in 2021, and almost 90% of those diagnoses will be UC.
  • Trodelvy is also being developed as an investigational treatment for hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER 2-) metastatic breast cancer and metastatic non-small cell lung cancer.
  • The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer.

LintonPharm Announces Authorization from China Health Authority (NMPA) to Proceed with a Phase 1/2 Trial Evaluating Catumaxomab for the treatment of Non-Muscle Invasive Bladder Cancer

Tuesday, April 13, 2021 - 1:00pm

\xe2\x80\x9cPatients with NMIBC BCG failure have high rates of tumor recurrence and often face a lifetime of surgical intervention which may impact bladder function.

Key Points: 
  • \xe2\x80\x9cPatients with NMIBC BCG failure have high rates of tumor recurrence and often face a lifetime of surgical intervention which may impact bladder function.
  • New treatment options are needed and we are hopeful that this study puts us one step closer toward helping these patients.\xe2\x80\x9d\nBladder cancer is the 10th most common cancer worldwide.
  • In 2020, bladder cancer was diagnosed in approximately 573,278 patients globally and approximately 1.8 million people were living with this form of cancer over a five-year period [1].
  • NMIBC is a cancer found in the tissue that lines the inner surface of the bladder and accounts for approximately 75 percent of all bladder cancer [2].

Oncocyte Presents New Data at 2021 American Association for Cancer Research Annual Meeting Demonstrating Potential for Pan-Cancer Utility of DetermaIO™

Saturday, April 10, 2021 - 6:31pm

The presentations featured studies of Oncocytes novel predictor of immunotherapy response, DetermaIO, demonstrating test performance in bladder cancer, now the third cancer type, suggesting potential applicability across multiple cancer types.

Key Points: 
  • The presentations featured studies of Oncocytes novel predictor of immunotherapy response, DetermaIO, demonstrating test performance in bladder cancer, now the third cancer type, suggesting potential applicability across multiple cancer types.
  • At the conference, Oncocyte debuted data in bladder cancer in two studies, including one highlighted in a podium presentation.
  • Taken together, these data support the potential use of the 27-gene DetermaIO test as a pan-cancer predictor of response to ICI therapy.
  • These statements include those pertaining to the data presented at the 2021 American Association for Cancer Research (AACR) Annual Meeting, the potential use of DetermaIO across multiple tumor types, and other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management.

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

Friday, April 9, 2021 - 3:10pm

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.

Dr. Thomas Cannell, President and CEO of Sesen Bio, and Dr. Michael Jewett, FRCSC, FACS, to Participate in Canaccord Genuity “Horizons in Oncology” Virtual Conference

Thursday, April 8, 2021 - 1:55pm

He has appeared before the FDA as an expert including the presentation that led to the historic approval of BCG for NMIBC.

Key Points: 
  • He has appeared before the FDA as an expert including the presentation that led to the historic approval of BCG for NMIBC.
  • Dr. Jewett has published more than 400 peer-reviewed papers, mostly in Uro-oncology and in technology assessment and medical informatics.
  • In December 2020, Dr. Jewett was appointed to the Order of Canada based on his achievements listed above, among others.
  • Sesen Bio, Inc. is a late-stage clinical company advancing targeted fusion protein therapeutics for the treatment of patients with cancer.

Sesen Bio Reports Fourth Quarter and Full-Year 2020 Financial Results and Significant Regulatory and Commercial Readiness Progress for the Company’s Lead Product Candidate Vicineum™

Monday, March 15, 2021 - 11:00am

The FDA also stated that they are not currently planning to hold an advisory committee meeting to discuss the BLA for Vicineum.

Key Points: 
  • The FDA also stated that they are not currently planning to hold an advisory committee meeting to discuss the BLA for Vicineum.
  • On March 5, 2021, Sesen Bio submitted the Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for Vicineum for the treatment of BCG-unresponsive NMIBC.
  • Under the Agreement, Qilu will be part of the contract manufacturing network for the global commercial supply of Vicineum.
  • Vicineum, a locally administered fusion protein, is Sesen Bios lead product candidate being developed for the treatment of BCG-unresponsive non-muscle invasive bladder cancer (NMIBC).

The Worldwide Urology Devices Industry is Expected to Reach $46 Billion by 2026 at a CAGR of 4.1% from 2021

Monday, March 8, 2021 - 8:45pm

6.2.2.4.1 High Prevalence of Prostate, Kidney, and Bladder Cancers to Drive the Demand for Resectoscopes

Key Points: 

6.2.2.4.1 High Prevalence of Prostate, Kidney, and Bladder Cancers to Drive the Demand for Resectoscopes

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

Monday, March 8, 2021 - 6:00am

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.

Sesen Bio Announces Conference Call with Neal Shore, M.D., FACS to Provide Clinical Perspective on the Company’s Lead Product Candidate Vicineum™

Tuesday, March 2, 2021 - 1:00pm

Neal Shore, M.D., FACS is the medical director of the Carolina Urologic Research Center and is an internationally recognized expert in Urologic Oncology.

Key Points: 
  • Neal Shore, M.D., FACS is the medical director of the Carolina Urologic Research Center and is an internationally recognized expert in Urologic Oncology.
  • Shore is a paid consultant to Sesen Bio and served as a clinical investigator for the Phase 2 and Phase 3 clinical trials of Vicineum for NMIBC.
  • Vicineum, a locally administered fusion protein, is Sesen Bios lead product candidate being developed for the treatment of high-risk non-muscle invasive bladder cancer (NMIBC).
  • Sesen Bio, Inc. is a late-stage clinical company advancing targeted fusion protein therapeutics for the treatment of patients with cancer.

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

Thursday, February 18, 2021 - 1:00pm

"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.