Bladder cancer

IMFINZI (durvalumab) Approved in the US for Extensive-Stage Small Cell Lung Cancer

Monday, March 30, 2020 - 12:00pm

IMFINZI, in combination with etoposide and either carboplatin or cisplatin, is indicated for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC).

Key Points: 
  • IMFINZI, in combination with etoposide and either carboplatin or cisplatin, is indicated for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC).
  • IMFINZI is also approved for previously treated patients with advanced bladder cancer in the US and a small number of other countries.
  • Tremelimumab is being tested in a clinical trial program in combination with IMFINZI in NSCLC, bladder cancer, head and neck cancer, liver cancer and blood cancers.
  • EGFR Mutation Testing on Cytological and Histological Samples in Non-Small Cell Lung Cancer: a Polish, Single Institution Study and Systematic Review of European Incidence.

CG Oncology Announces License and Commercialization Agreement with Kissei Pharmaceutical Co., Ltd. for CG0070 in Japan and Other Asian Countries

Friday, March 27, 2020 - 12:00am

CG Oncology, Inc. has announced today an exclusive license, development and commercialization agreement with Kissei Pharmaceutical Co., Ltd. ("Kissei") for its oncolytic immunotherapy drug CG0070 for Japan, South Korea, Taiwan and other Asian countries with the exception of China.

Key Points: 
  • CG Oncology, Inc. has announced today an exclusive license, development and commercialization agreement with Kissei Pharmaceutical Co., Ltd. ("Kissei") for its oncolytic immunotherapy drug CG0070 for Japan, South Korea, Taiwan and other Asian countries with the exception of China.
  • CG Oncology has completed an investigational Phase 2 study of CG0070 in the United States in patients with BCG-unresponsive, non-muscle-invasive bladder cancer (NMIBC).
  • In addition, CG Oncology is studying the use of CG0070 in combination with immune checkpoint inhibitors in bladder cancer and other solid tumors.
  • In addition, CG Oncology is exploring the use of CG0070 in combination with immune checkpoint inhibitors in different solid tumors.

Global Bladder Cancer Market, 2020 - ResearchAndMarkets.com

Tuesday, March 24, 2020 - 3:20pm

The latest report Bladder Cancer: Opportunity Analysis and Forecasts to 2028, provides an overview of bladder cancer, including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and disease management.

Key Points: 
  • The latest report Bladder Cancer: Opportunity Analysis and Forecasts to 2028, provides an overview of bladder cancer, including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and disease management.
  • The report further brings in annualized bladder cancer therapeutics market revenue, strategic competitor assessment, clinical trial mapping, pipeline drug analysis and analysis of the current and future market competition in the global bladder cancer market.
  • Key topics covered include strategic competitor assessment, market characterization, unmet needs, clinical trial mapping and implications for the bladder cancer therapeutics market.
  • Analysis of the current and future market competition in the global bladder cancer market.

Dr. Thomas Cannell, President and CEO of Sesen Bio, to Host Conference Call to Provide Business Update Highlighting Regulatory Progress and Commercial Opportunity for Vicinium®

Tuesday, February 25, 2020 - 9:30pm

ET to provide an overview of 2019 operational performance and key updates on the Companys regulatory progress and commercial opportunity for Vicinium.

Key Points: 
  • ET to provide an overview of 2019 operational performance and key updates on the Companys regulatory progress and commercial opportunity for Vicinium.
  • To participate in the conference call, please dial (844) 831-3025 (domestic) or (315) 625-6887 (international) and refer to conference ID 1497176.
  • Vicinium, 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.

CicloMed Presents New Oncology Data from Phase I Trial with Fosciclopirox at 2020 ASCO Genitourinary Cancers Symposium

Thursday, February 13, 2020 - 2:15pm

Results from the recently completed first-in-human Phase 1 dose escalation study in patients with advanced solid tumors will be presented.

Key Points: 
  • Results from the recently completed first-in-human Phase 1 dose escalation study in patients with advanced solid tumors will be presented.
  • A second poster describes the fosciclopirox Phase I expansion cohort study in cisplatin-ineligible muscle-invasive bladder cancer (MIBC) patients currently underway at two U.S. sites.
  • This window of opportunity trial is characterizing the safety, dose tolerance, pharmacokinetics and pharmacodynamics of fosciclopirox administered at the RP2D in 12 MIBC patients scheduled for cystectomy.
  • CicloMed is a developmental-stage pharmaceutical company focusing on unmet medical needs in oncology, and fosciclopirox (formerly Ciclopirox Prodrug, CPX-POM) is its lead drug development candidate.

FerGene to Present Bladder Cancer Data at 2020 ASCO Genitourinary Cancers Symposium

Monday, February 10, 2020 - 10:43pm

FerGene, a newly created gene therapy company committed to revolutionizing the treatment of bladder cancer, today announced it will present research at the 2020 American Society of Clinical Oncology (ASCO) Genitourinary Cancers Symposium taking place February 13-15 in San Francisco, California.

Key Points: 
  • FerGene, a newly created gene therapy company committed to revolutionizing the treatment of bladder cancer, today announced it will present research at the 2020 American Society of Clinical Oncology (ASCO) Genitourinary Cancers Symposium taking place February 13-15 in San Francisco, California.
  • The virus is designed to enter the cells of the bladder wall, where it breaks down, releasing the active gene to do its work.
  • This novel gene therapy approach thereby uses the patients own bladder wall cells to produce interferon, enhancing the bodys natural defenses against the cancer.
  • 5 Cookson, M et al., Use of intravesical valrubicin in clinical practice for treatment of nonmuscle-invasive bladder cancer, including carcinoma in situ of the bladder.

Genentech Provides an Update on Phase III Study of Tecentriq in People With Muscle-invasive Urothelial Cancer

Friday, January 24, 2020 - 6:00am

Safety for Tecentriq appeared consistent with the known safety profile of the medicine, and no new safety signals were identified.

Key Points: 
  • Safety for Tecentriq appeared consistent with the known safety profile of the medicine, and no new safety signals were identified.
  • In addition to ongoing Phase III studies in early and advanced bladder cancer, Genentech has an extensive development program for Tecentriq, including multiple ongoing and planned Phase III studies across genitourinary, skin, breast, gastrointestinal, gynecological and head and neck cancers.
  • Urothelial cancer is the most common type of bladder cancer, accounting for about 90-95% of all cases.
  • Tecentriq is a prescription medicine used to treat adults with:
    A type of bladder and urinary tract cancer called urothelial carcinoma.

miR Scientific® Introduces New Paradigm for Precision Medicine at PMWC 2020

Tuesday, January 21, 2020 - 3:13pm

NEW YORK, Jan. 21, 2020 /PRNewswire/ -- miR Scientific LLC , a precision bioscience company focused on comprehensive disease detection and management, announced that CEO and Co-Founder Sam Salman will give a presentation on the company's approach to creating a new precision medicine paradigm with the Sentinel Disease Management Platform at the Precision Medicine World Conference (PMWC 2020) in Santa Clara, California on Thursday, January 23, 2020.

Key Points: 
  • NEW YORK, Jan. 21, 2020 /PRNewswire/ -- miR Scientific LLC , a precision bioscience company focused on comprehensive disease detection and management, announced that CEO and Co-Founder Sam Salman will give a presentation on the company's approach to creating a new precision medicine paradigm with the Sentinel Disease Management Platform at the Precision Medicine World Conference (PMWC 2020) in Santa Clara, California on Thursday, January 23, 2020.
  • This includes the miR Scientific Sentinel PCa Testfor prostate cancer and similar liquid biopsy tests for bladder cancerthe miR Scientific Sentinel BCa Testfor detecting bladder cancer, and the miR Scientific Sentinel BCR Testfor identifying recurrent bladder cancer.
  • We aim to improve day-to-day care for patients and positively impact the cost of healthcare for payors, employers and other stakeholders worldwide.
  • miR Scientificis a majority-owned operating subsidiary of Impact NRS LLC, headquartered in New York with operating subsidiaries in Canada and Israel.

KDx Diagnostics announces FDA Breakthrough Device designation for URO17™, Innovative urine test for Bladder Cancer

Thursday, January 9, 2020 - 1:28am

CAMPBELL, Calif., Jan. 8, 2020 /PRNewswire/ --KDx Diagnostics, Inc. (KDx), announced today that the Food and Drug Administration (FDA) has granted "Breakthrough Device" designation for its URO17 Bladder Cancer Recurrence Test.

Key Points: 
  • CAMPBELL, Calif., Jan. 8, 2020 /PRNewswire/ --KDx Diagnostics, Inc. (KDx), announced today that the Food and Drug Administration (FDA) has granted "Breakthrough Device" designation for its URO17 Bladder Cancer Recurrence Test.
  • This revolutionary new test exploits a novel cancer marker that could dramatically improve the accuracy and sensitivity of non-invasive bladder cancer testing.
  • "The FDA's designation of Breakthrough Device for our URO17 test validates our excitement about the potential of our test to improve bladder cancer treatment with attendant major impact in the marketplace for bladder cancer diagnostics.
  • The URO17 bladder cancer test developed by KDx may prove to be the most sensitive and specific test for bladder cancer developed to date.

FDA Approves Merck’s KEYTRUDA® (pembrolizumab) for Patients With BCG-Unresponsive, High-Risk, Non-Muscle Invasive Bladder Cancer With Carcinoma In Situ With or Without Papillary Tumors Who Are Ineligible for or Have Elected Not to Undergo Cystectomy

Wednesday, January 8, 2020 - 9:31pm

Historically, patients with high-risk, non-muscle invasive bladder cancer with CIS whose cancer is unresponsive to BCG treatment had limited non-surgical treatment options.

Key Points: 
  • Historically, patients with high-risk, non-muscle invasive bladder cancer with CIS whose cancer is unresponsive to BCG treatment had limited non-surgical treatment options.
  • The safety of KEYTRUDA was investigated in KEYNOTE-057, which enrolled 148 patients with high-risk NMIBC, 96 of whom had BCG-unresponsive CIS with or without papillary tumors.
  • KEYTRUDA is indicated for the adjuvant treatment of patients with melanoma with involvement of lymph node(s) following complete resection.
  • Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving KEYTRUDA.