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News Flash 12.2023

In the middle of December, the Food and Drug Administration (FDA) approved Enfortumab vedotin (Padcev) in combination with Keytruda (a type of immunotherapy) for the treatment of patients recently diagnosed with advanced or metastatic urothelial cancer.

Padcev is an antibody-drug conjugate (an antibody attached to a chemotherapy agent). 

The antibody delivers the chemotherapy drug directly to certain cancer cells.

The approval was based on results from a clinical trial in which 886 patients meeting the abovementioned criteria were enrolled. Patients were randomly assigned to receive either Padcev combined with Keytruda (study group), or standard chemotherapy (control group).

At the end of the follow-up period, results pointed towards a significantly lower risk of disease progression among the study group patients receiving Padcev combined with Keytruda, compared to the control group patients receiving standard chemotherapy.  

Furthermore, a significantly lower death rate was observed among patients in the study group, compared to those in the control group.

Padcev in combination with Keytruda provides an efficient treatment for patients recently diagnosed with advanced or metastatic urothelial cancer.

It is important to note that Padcev may cause serious side effects, also reflected in abnormal laboraty test results, thus patients receiving it require careful monitoring throughout treatment.