FDA approves Seattle Genetics and Astellas Pharma’s bladder cancer drug
The FDA has granted accelerated approval for Seattle Genetics and Astellas Pharma’s bladder cancer drug Padcev (enfortumab vedotin-ejfv).
The drug’s most recent results come from a Phase 2 trial that contained 125 patients with locally advanced or metastatic urothelial cancer.
When treated with single-agent Padcev in the trial, 12% of patients exhibited a complete response, implying there was no identifiable cancer during the evaluation. 32% of patients exhibited a partial response in the study, indicating a decrease in tumour size or the extent of cancer in the body.
Dr Andrew Krivoshik, the Senior Vice President of Astellas, said: “This approval underscores our commitment to develop novel medicines that address unmet patient needs, and we’re grateful to the patients and physicians whose participation led to this outcome.”
Padcev has been designed for adults who have either locally advanced or metastatic urothelial cancer, and have already received a PD-1/L1 inhibitor and a platinum-containing chemotherapy before (neoadjuvant) or after (adjuvant) surgery or in a locally advanced or metastatic setting.
Dr Roger Dansey, Seattle Genetics Chief Medical Officer, said: “Padcev is the first antibody-drug conjugate approved for patients facing this aggressive disease, and it is the culmination of years of innovative work on this technology.”
It is estimated that 17,670 deaths from the disease will occur by the end of this year. Among men, bladder cancer is the eighth most common cause of cancer death.
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