- PDUFA target date is 1/18/19
- Sacituzumab govitecan is an antibody drug conjugate (ADC)
- If appproved it would be the first ADC approved for mTNBC
- Company has another ADC in Ph II for metastatic colorectal cancer
Immunomedics, Inc., (NASDAQ:IMMU) announced on 7/18/18 that the U.S. Food and Drug Administration (FDA) has accepted the Company’s Biologics License Application (BLA) for filing and granted Priority Review 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. The PDUFA target action date is January 18, 2019. If approved, sacituzumab govitecan would be the first and only antibody-drug conjugate (ADC) approved for the treatment of mTNBC.
“We are delighted that the FDA has accepted the sacituzumab govitecan BLA for Priority Review,” commented Michael Pehl, President and Chief Executive Officer. “We will continue to work closely with the regulatory agency as we strive to bring this potential new treatment to mTNBC patients expeditiously.”
The filing is based on Phase 1/2 data of sacituzumab govitecan in mTNBC.
Sacituzumab govitecan, Immunomedics’ most advanced product candidate, is a novel, first-in-class antibody-drug conjugate (ADC). It is currently under review by the U.S. Food and Drug Administration for accelerated approval as a treatment of patients with metastatic triple-negative breast cancer 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 metastatic triple-negative breast cancer.
Sacituzumab govitecan is also being studied in other solid tumors including: urothelial, lung, endometrial, and prostate. The company also has seven additional candidates under development or consideration for development. In addition to sacituzumab govitecan the company also has another ADC, labetuzumab govitecan, in Ph II trials for metastatic colorectal cancer. The two ADCs facilitate targeted delivery of SN-38, the active metabolite of irinotecan, an effective, yet toxic chemotherapeutic, more directly to tumor cells. While sacituzumab govitecan and labetuzumab govitecan are circulating in the blood stream, the novel and proprietary ADC linking system keeps SN-38 conjugated to the antibody and in an inactive form.
As of this writing shares are up 4+% in pre-market trading.