Glembatumumab vedotin

Istari Oncology Announces FDA Granted Fast Track Designation to PVSRIPO for the Treatment of Advanced Melanoma

Retrieved on: 
Monday, June 14, 2021

In addition to Fast Track designation, FDA granted Orphan Drug Designation to PVSRIPO for the treatment of advanced melanoma earlier this year.

Key Points: 
  • In addition to Fast Track designation, FDA granted Orphan Drug Designation to PVSRIPO for the treatment of advanced melanoma earlier this year.
  • Treatment-resistant, advanced melanoma patients have very poor survival rates, with less than 30% of metastatic melanoma patients surviving 5 years1.
  • Fast Track is an FDA program designed to facilitate the expedited development of drugs to treat serious conditions and address an unmet medical need.
  • We are thrilled with FDAs decision to grant both Fast Track and Orphan Drug Designation to PVSRIPO for the treatment of advanced melanoma, said Matt Stober, President and Chief Executive Officer at Istari Oncology.

Breakthrough Immunotherapy Earns First Regulatory Approval for Triple Negative Breast Cancer (TNBC)

Retrieved on: 
Tuesday, March 23, 2021
Key Points: 
  • View the full release here: https://www.businesswire.com/news/home/20210323005283/en/
    Immunopheresis LW-02 blood-filtering column is a leading immuno-oncology product with FDA Breakthrough Device status and regulatory clearance (CE Mark certification) in Europe for use in adults with advanced, refractory triple negative breast cancer (TNBC).
  • TNBC accounts for up to 20% of breast cancer cases and is much more aggressive and often carries a worse prognosis than other forms of breast cancer.
  • Triple-negative breast cancer (TNBC) has fewer treatment options than other types of invasive breast cancer.
  • Immunicoms lead product, the LW-02 column, has received U.S. FDA Breakthrough Device designation for stage IV metastatic cancer and European regulatory clearance (CE Mark certification) for use in adults with advanced, refractory, triple negative breast cancer (TNBC).

Genmab and Seattle Genetics Present Data from Tisotumab Vedotin innovaTV 204 Pivotal Trial in Recurrent or Metastatic Cervical Cancer at ESMO Virtual Congress 2020

Retrieved on: 
Monday, September 21, 2020

Genmab A/S (Nasdaq: GMAB) and Seattle Genetics, Inc. (Nasdaq: SGEN) today presented data from the innovaTV 204 pivotal phase 2, single-arm clinical trial evaluating tisotumab vedotin as monotherapy in patients with previously treated recurrent and/or metastatic cervical cancer at the European Society for Medical Oncology (ESMO) Virtual Congress 2020.

Key Points: 
  • Genmab A/S (Nasdaq: GMAB) and Seattle Genetics, Inc. (Nasdaq: SGEN) today presented data from the innovaTV 204 pivotal phase 2, single-arm clinical trial evaluating tisotumab vedotin as monotherapy in patients with previously treated recurrent and/or metastatic cervical cancer at the European Society for Medical Oncology (ESMO) Virtual Congress 2020.
  • Tisotumab vedotin has demonstrated meaningful clinical activity in patients with recurrent and/or metastatic cervical cancer for whom there is a high unmet need for new therapies, said Roger Dansey, M.D., Chief Medical Officer at Seattle Genetics.
  • Data presented at ESMO include the primary endpoint of confirmed ORR as assessed by independent central review in 101 patients treated with tisotumab vedotin in the trial.
  • For more information about the phase 2 innovaTV 204 clinical trial and other clinical trials with tisotumab vedotin, please visit www.clinicaltrials.gov.

Seattle Genetics and Genmab Present Data from Tisotumab Vedotin innovaTV 204 Pivotal Trial in Recurrent or Metastatic Cervical Cancer at ESMO Virtual Congress 2020

Retrieved on: 
Monday, September 21, 2020

Seattle Genetics, Inc. (Nasdaq:SGEN) and Genmab A/S (Nasdaq: GMAB) today presented data from the innovaTV 204 pivotal phase 2, single-arm clinical trial evaluating tisotumab vedotin as monotherapy in patients with previously treated recurrent and/or metastatic cervical cancer at the European Society for Medical Oncology (ESMO) Virtual Congress 2020.

Key Points: 
  • Seattle Genetics, Inc. (Nasdaq:SGEN) and Genmab A/S (Nasdaq: GMAB) today presented data from the innovaTV 204 pivotal phase 2, single-arm clinical trial evaluating tisotumab vedotin as monotherapy in patients with previously treated recurrent and/or metastatic cervical cancer at the European Society for Medical Oncology (ESMO) Virtual Congress 2020.
  • We are encouraged by the innovaTV 204 trial results, which suggests that tisotumab vedotin as a monotherapy could potentially become an important option for women with metastatic and or recurrent cervical cancer, said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.
  • Data presented at ESMO include the primary endpoint of confirmed ORR as assessed by independent central review in 101 patients treated with tisotumab vedotin in the trial.
  • For more information about the phase 2 innovaTV 204 clinical trial and other clinical trials with tisotumab vedotin, please visit www.clinicaltrials.gov.

Immunomedics Announces FDA Approval of Samsung Biologics as Antibody Manufacturer for Trodelvy™

Retrieved on: 
Monday, August 17, 2020

This approval enhances our ability to supply commercial product to the U.S. market, where the unmet need across our lead indications is very high.

Key Points: 
  • This approval enhances our ability to supply commercial product to the U.S. market, where the unmet need across our lead indications is very high.
  • We have been using drug product that were produced with antibody manufactured by Samsung in clinical trials in the U.S. over the course of 2020, and we now look forward to further scaling our commercial supply of Trodelvy globally.
  • Trodelvy is the first ADC the FDA has approved for the treatment of people with metastatic triple-negative breast cancer.
  • Immunomedics is a leader in next-generation antibody-drug conjugate (ADC) technology, committed to help transform the lives of people with hard-to-treat cancers.

Seattle Genetics Announces Positive Topline Results from Phase 2 Clinical Trial of Tisotumab Vedotin in Recurrent or Metastatic Cervical Cancer

Retrieved on: 
Monday, June 29, 2020

Seattle Genetics, Inc. (Nasdaq:SGEN) today announced positive topline results from the phase 2 single-arm clinical trial known as innovaTV 204 evaluating tisotumab vedotin administered every three weeks for the treatment of patients who have relapsed or progressed on or after prior treatment for recurrent or metastatic cervical cancer.

Key Points: 
  • Seattle Genetics, Inc. (Nasdaq:SGEN) today announced positive topline results from the phase 2 single-arm clinical trial known as innovaTV 204 evaluating tisotumab vedotin administered every three weeks for the treatment of patients who have relapsed or progressed on or after prior treatment for recurrent or metastatic cervical cancer.
  • Despite these advances, women are still diagnosed with cervical cancer, which often recurs or becomes metastatic.
  • For more information about the phase 2 innovaTV 204 clinical trial and other clinical trials with tisotumab vedotin, please visit www.clinicaltrials.gov.
  • Tisotumab vedotin is being evaluated in ongoing clinical trials as monotherapy in a range of solid tumors, including recurrent and/or metastatic cervical cancer, ovarian cancer and in combination with other commonly used therapies in recurrent or metastatic cervical cancer.

Oncocyte Announces Peer-Reviewed Publication of Data Demonstrating the Potential of its TNBCType Assay to Inform Triple Negative Breast Cancer Drug Development

Retrieved on: 
Tuesday, May 5, 2020

Breast cancer is the most common cancer with more than 1.6 million new cases diagnosed annually in the world.

Key Points: 
  • Breast cancer is the most common cancer with more than 1.6 million new cases diagnosed annually in the world.
  • In the United States, the overall 5-Year survival rates in breast cancer are over 90%, but survival rates for triple negative breast cancer (TNBC) are lower at 77%.
  • The Company believes that the assay may be an attractive companion diagnostic candidate for proprietary therapeutics in development at biopharmaceutical companies.
  • This information will help bridge the gap between drug development and the potential use of TNBCtype for making clinical decisions.

Multimedia Update: FDA Grants Accelerated Approval for Immunomedics’ Trodelvy in Previously-Treated Metastatic Triple-Negative Breast Cancer

Retrieved on: 
Thursday, April 23, 2020

In our trial, Trodelvy demonstrated clinically meaningful responses in patients with difficult-to-treat metastatic TNBC and moves the needle towards better outcomes for patients with metastatic breast cancer.

Key Points: 
  • In our trial, Trodelvy demonstrated clinically meaningful responses in patients with difficult-to-treat metastatic TNBC and moves the needle towards better outcomes for patients with metastatic breast cancer.
  • We are committed to broadening the potential use of Trodelvy in other Trop-2-expressing cancers, especially those with unmet need.
  • TRODELVY, our lead ADC, is the first ADC FDA approved for the treatment of people with metastatic triple-negative breast cancer and is also the first FDA-approved anti-Trop-2 ADC.
  • Current treatment landscape for patients with locally recurrent inoperable or metastatic triple-negative breast cancer: a systematic literature review.

FDA Grants Accelerated Approval for Immunomedics’ Trodelvy in Previously-Treated Metastatic Triple-Negative Breast Cancer

Retrieved on: 
Wednesday, April 22, 2020

In our trial, Trodelvy demonstrated clinically meaningful responses in patients with difficult-to-treat metastatic TNBC and moves the needle towards better outcomes for patients with metastatic breast cancer.

Key Points: 
  • In our trial, Trodelvy demonstrated clinically meaningful responses in patients with difficult-to-treat metastatic TNBC and moves the needle towards better outcomes for patients with metastatic breast cancer.
  • We are committed to broadening the potential use of Trodelvy in other Trop-2-expressing cancers, especially those with unmet need.
  • TRODELVY, our lead ADC, is the first ADC FDA approved for the treatment of people with metastatic triple-negative breast cancer and is also the first FDA-approved anti-Trop-2 ADC.
  • Current treatment landscape for patients with locally recurrent inoperable or metastatic triple-negative breast cancer: a systematic literature review.

Triple-Negative Breast Cancer Global Clinical Trials Review, H2, 2019 - Pfizer Inc, Novartis AG, Eisai Co Ltd & Bayer AG - ResearchAndMarkets.com

Retrieved on: 
Thursday, January 30, 2020

The "Triple-Negative Breast Cancer (TNBC) Global Clinical Trials Review, H2, 2019" clinical trials has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Triple-Negative Breast Cancer (TNBC) Global Clinical Trials Review, H2, 2019" clinical trials has been added to ResearchAndMarkets.com's offering.
  • The clinical trial report, Triple-Negative Breast Cancer (TNBC) Global Clinical Trials Review, H2, 2019 provides an overview of Triple-Negative Breast Cancer (TNBC) clinical trials scenario.
  • The report offers coverage of disease clinical trials by region, country (G7 & E7), phase, trial status, end points status and sponsor type.
  • Clinical trials are collated from 80+ different clinical trial registries, conferences, journals, news etc across the globe.