First-in-Class Antibody-Drug Conjugate had Received Prior Breakthrough Therapy Designation from the FDA for the Treatment of Metastatic Triple-Negative Breast Cancer
MORRIS PLAINS, NJ, USA I May 21, 2018 I Immunomedics, Inc., (NASDAQ:IMMU) (“Immunomedics” or the “Company”), a science-based and innovation-focused biopharmaceutical company committed to the development and worldwide commercialization of its unique and proprietary antibody-drug conjugate (ADC) platform, today announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for sacituzumab govitecan for the treatment of patients with metastatic triple-negative breast cancer (mTNBC) who previously received at least two prior therapies for metastatic disease. If approved, sacituzumab govitecan would be the first and only ADC approved for the treatment of mTNBC.
“The treatment of TNBC clearly represents an area of high unmet medical need and there are currently only very limited treatment options for mTNBC patients,” said Michael Pehl, President and Chief Executive Officer. “Further, the BLA submission of sacituzumab govitecan represents a significant milestone for Immunomedics on our path to unlock the future promise of our unique ADC platform for patients and healthcare professionals. We greatly thank the patients that participated in our trials along with their caregivers, and look forward to working closely with the FDA.”
The filing is based on Phase 1/2 data of sacituzumab govitecan in mTNBC.
About Immunomedics
Immunomedics is a clinical-stage biopharmaceutical company developing monoclonal antibody-based products for the targeted treatment of cancer and other serious diseases. Immunomedics’ corporate objective is to become a fully-integrated biopharmaceutical company and a leader in the field of antibody-drug conjugates. For additional information on the Company, please visit its website at https://immunomedics.com/. The information on its website does not, however, form a part of this press release.
SOURCE: Immunomedics
Post Views: 28
First-in-Class Antibody-Drug Conjugate had Received Prior Breakthrough Therapy Designation from the FDA for the Treatment of Metastatic Triple-Negative Breast Cancer
MORRIS PLAINS, NJ, USA I May 21, 2018 I Immunomedics, Inc., (NASDAQ:IMMU) (“Immunomedics” or the “Company”), a science-based and innovation-focused biopharmaceutical company committed to the development and worldwide commercialization of its unique and proprietary antibody-drug conjugate (ADC) platform, today announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for sacituzumab govitecan for the treatment of patients with metastatic triple-negative breast cancer (mTNBC) who previously received at least two prior therapies for metastatic disease. If approved, sacituzumab govitecan would be the first and only ADC approved for the treatment of mTNBC.
“The treatment of TNBC clearly represents an area of high unmet medical need and there are currently only very limited treatment options for mTNBC patients,” said Michael Pehl, President and Chief Executive Officer. “Further, the BLA submission of sacituzumab govitecan represents a significant milestone for Immunomedics on our path to unlock the future promise of our unique ADC platform for patients and healthcare professionals. We greatly thank the patients that participated in our trials along with their caregivers, and look forward to working closely with the FDA.”
The filing is based on Phase 1/2 data of sacituzumab govitecan in mTNBC.
About Immunomedics
Immunomedics is a clinical-stage biopharmaceutical company developing monoclonal antibody-based products for the targeted treatment of cancer and other serious diseases. Immunomedics’ corporate objective is to become a fully-integrated biopharmaceutical company and a leader in the field of antibody-drug conjugates. For additional information on the Company, please visit its website at https://immunomedics.com/. The information on its website does not, however, form a part of this press release.
SOURCE: Immunomedics
Post Views: 28
