(Reuters) – Immunomedics Inc won an accelerated approval from the U.S. Food and Drug Administration for Trodelvy, its therapy for a form of invasive breast cancer that has worsened despite two prior rounds of treatment, the company said on Wednesday.
Trodelvy injection, approved to treat metastatic triple-negative breast cancer, comes with 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 cell. (https://bit.ly/2XW5G3z)
The therapy’s label specified that its continued approval may depend upon verification of clinical benefit in supporting trials.
The FDA had declined to grant accelerated approval for the breast cancer therapy in January last year https://www.reuters.com/article/us-immunomedics-fda/immunomedics-cancer-treatment-fails-to-win-accelerated-approval-from-the-fda-idUSKCN1PC03G.
Patients with triple-negative breast cancer test negative for hormone receptors or HER2, meaning their tumors do not respond to hormone therapy or to therapies like Roche’s blockbuster Herceptin.
As per the U.S. Centers for Disease Control and Prevention, breast cancer is the second most common cancer among women in the United States with 41,487 women dying of female breast cancer in 2016 https://gis.cdc.gov/Cancer/USCS/DataViz.html, the latest year for which data is available. Triple-negative breast cancer accounts for about 10-15% of all breast cancers, according to the American Cancer Society.
(Reporting by Saumya Sibi Joseph and Shivani Singh in Bengaluru; Editing by Maju Samuel and Shailesh Kuber)