The positive new data could improve Immunomedics' chances of winning full U.S. Food and Drug Administration (FDA) approval for Trodelvy, the lead drug of the Morris Plains, New Jersey-based cancer drugmaker. Immunomedics is being acquired by Gilead Sciences Inc for $21 billion under a deal announced on Sept. 14.
The FDA granted the drug accelerated approval for its use in metastatic triple-negative breast cancer (mTNBC) patients who had previously received at least two prior therapies. Its continued approval is contingent upon the FDA's verification of a clinical benefit in confirmatory trials.
Trodelvy reduced the risk of death by 52 percent, with a median overall survival of 12.1 months for patients receiving the drug in the late-stage confirmatory trial compared to 6.7 months for patients receiving chemotherapy, Immunomedics said.
Immunomedics said it would file for full FDA approval of Trodelvy in the fourth quarter under the FDA's Real-Time Oncology Review (RTOR) process that allows the agency to review the data before the company submits its marketing application.
Trodelvy is an antibody-drug conjugate that delivers an anti-cancer drug called SN-38 directly to cancer cells by binding to a protein called Trop-2 found on their surface.
It is also being tested in multiple ongoing clinical trials for its potential use against urothelial cancer, non-small cell lung cancer and other forms of breast cancer, the company said.
Trodelvy's current label carries a boxed warning - the FDA's harshest - that flags risks of severe diarrhea and neutropenia, an abnormally low count of a type of white blood cells.
The results were due to be presented at the European Society for Medical Oncology meeting on Saturday, the company said.
By Manojna Maddipatla
Posted on
site created by:
© 2024 Medicom Medical Publishers. All rights reserved. Terms and Conditions | Privacy Policy
HEAD OFFICE
Laarderhoogtweg 25
1101 EB Amsterdam
The Netherlands
T: +31 85 4012 560
E: publishers@medicom-publishers.com