Padcev FDA approval : Astellas Pharma and Seattle Genetics have bagged accelerated approval from the US Food and Drug Administration (FDA) for Padcev (enfortumab vedotin-ejfv) for the treatment of advanced urothelial cancer, the most common form of bladder cancer.

Padcev, which has been co-developed by the two pharma companies, is a Nectin-4-directed antibody and microtubule inhibitor conjugate, which in particular targets cancer cells. The drug targets the cell adhesion molecule Nectin-4, which is expressed highly in urothelial cancers.

Padcev FDA approval is for the treatment of adults having locally advanced or metastatic urothelial cancer who previously underwent treatment with a programmed death receptor-1 (PD-1) or programmed death ligand 1 (PD-L1) inhibitor and a platinum-based chemotherapy.

According to the FDA, Padcev marks a new type of treatment for advanced urothelial cancer whose disease patients whose condition has progressed on chemotherapy and immunotherapy.

Commenting on Padcev FDA approval, Richard Pazdur – director of the FDA’s Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the FDA’s Center for Drug Evaluation and Research, said: “Antibody-drug conjugates are strategic tools in the targeted treatment of cancer. These conjugates combine the ability of monoclonal antibodies to target specific receptors on cancer cells and then deliver a drug to the cancer cell.

“Padcev is an antibody-drug conjugate that targets Nectin-4, a cell surface protein expressed on bladder cancer cells and a cell-killing agent, monomethyl auristantin E.”

Enfortumab vedotin FDA approval was based on the findings of the EV-201 phase 2 clinical trial that featured 125 patients having locally advanced or metastatic urothelial cancer who had prior treatment with a PD-1 or PD-L1 inhibitor and platinum-based chemotherapy. The overall response rate, which is the percentage of patients who had a certain amount of tumor shrinkage, was 44%, of which 12% had a complete response and 32% had a partial response. The median duration of response for the patients was 7.6 months.

Andrew Krivoshik – Senior Vice President and Oncology Therapeutic Area Head at Astellas Pharma, commenting on Padcev FDA approval, 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.”

Accelerated approval to a drug is given by the FDA for serious conditions to fill an unmet medical need. The approval is granted based on a result that is reasonably likely to predict a clinical benefit to patients.

Astellas Pharma and Seattle Genetics will need a further clinical trial to verify and describe the clinical benefit of Padcev in advanced urothelial cancer.

The new urothelial cancer was previously given priority review and breakthrough therapy designation by the FDA, which granted it approval almost three months before the goal date.

  Andrew Krivoshik, Astellas, Astellas Pharma, bladder cancer, cancer, Oncology, Richard Pazdur, Seattle Genetics, urothelial cancer, US Food and Drug Administration