Astellas Pharma Inc. has confirmed that they have submitted a Supplemental New Drug Application, or sNDA, to the Ministry of Health, Labour and Welfare in Japan. Their aim is to get approval for a combination therapy of PADCEV and KEYTRUDA as an initial treatment method for adult patients. These patients would comprise those who have not yet been treated for locally advanced or metastatic urothelial cancer.
If the authorities give their approval, the combined PADCEV and KEYTRUDA could potentially revolutionize the treatment plan for urothelial cancer patients. It could become the first alternative treatment to platinum-containing chemotherapy, which currently stands as the main treatment option for first-line locally advanced or metastatic urothelial cancer, according to a statement by Astellas.
The Committee for Medicinal Products for Human Use, part of the European Medicines Agency, is currently reviewing this combination therapy as well. The U.S. Food and Drug Administration granted approval for this combined therapy in December 2023. To get more health news like this, check out rttnews.com.
