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Gilead recently announced that Health Canada has approved its targeted anticancer drug Trodelvy (sacituzumab govitecan-hziy, gosartuzumab) through the Orbis program (Project Orbis) for the treatment of metastases Adult patients with sexual triple negative breast cancer (mTNBC)
It is worth mentioning that Trodelvy is the first therapy to show superiority to standard care in the treatment of metastatic TNBC, marking a major advancement in the treatment of TNBC
This Canadian approval also marks the fifth approval that Trodelvy has obtained through the Orbis program
Trodelvy structural features (picture source: broadpharm.
Trodelvy is a new and pioneering antibody-conjugated drug (ADC) targeting Trop-2.
Trodelvy was developed by Immunomedics.
In the United States, Trodelvy has been approved for 2 indications: (1) For the treatment of unresectable locally advanced or metastatic TNBC adult patients who have previously received at least 2 therapies, including at least 1 therapy for metastatic disease; ( 2) For the treatment of locally advanced or metastatic urothelial carcinoma (UC) adult patients who have previously received platinum-containing chemotherapy and PD-1 inhibitors or PD-L1 inhibitors
In China, Trodelvy (Gosartuzumab) was included in the 2020 edition of the "Guidelines for the Standardized Diagnosis and Treatment of Advanced Breast Cancer in China" in October 2020.
Breast cancer is the most common type of cancer among women, with more than 2 million cases diagnosed globally each year
Trodelvy's regulatory approval is based on the results of the Phase 3 ASCENT (NCT02574455) trial
The results showed that the study reached the primary and key secondary endpoints: Compared with the chemotherapy group, the Trodelvy group had a statistically significant improvement in PFS (median PFS: 4.
Note: The original text has been deleted
Original source: Gilead Marks Fifth Approval for Trodelvy in Metastatic Triple-Negative Breast Cancer Under Project Orbis Initiative with Health Canada Authorization
