US FDA Approves Astellas' Combination Therapy for Bladder Cancer

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12/19/2023

The U.S. Food and Drug Administration on Friday approved Astellas Pharma's (4503.T) Padcev in combination with Merck's (MRK.N) Keytruda for a type of bladder cancer.

In April, FDA had granted accelerated approval to this combination for treating patients suffering from the disease that are ineligible for chemotherapy with the commonly used cancer drug, cisplatin.

The FDA said on Friday the approval was based on a late-stage trial where the combination therapy met major efficacy outcomes of overall survival and progression-free survival, which is how long a patient lives without the disease getting worse after treatment.

The decision marks another win for Astellas after the FDA approved its chronic eye disease drug, Izervay, in August.

Astellas developed Padcev in collaboration with Seagen, which is owned by Pfizer (PFE.N).

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