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Padcev received approval for advanced urothelial cancer

The U.S Food and Drug Administration has given accelerated approval for Astellas’ and Seattle Genetics’ Padcev (enfortumab vedotin-ejfv), a Nectin-4-directed antibody and microtubule inhibitor conjugate. Nectin-4 is highly expressed in urothelial cancer, making the drug specifically inhibit urothelial cancer.


The drug is indicated for locally advanced (when cancer has grown too large to be surgically removed) or metastatic (when cancer cells spread to other parts of the body) urothelial cancer.


Urothelial cancer is the sixth most common cancer in the U.S, accounting for 90% of bladder cancers. FDA stated that Padcev represents a new therapy, in patients in whom cancer advance after treating with chemotherapy and immunotherapy.


“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,” said Richard Pazdur, M.D., director of the FDA’s Oncology Center of Excellence.


“This approval underscores our commitment to developing novel medicines that address unmet patient needs, and we’re grateful to the patients and physicians whose participation led to this outcome,” said Andrew Krivoshik, Senior Vice President and Oncology Therapeutic Area Head, Astellas.


The drug is approved based on EV-201, a single-arm phase 2 multi-center trial which included 125 patients with locally advanced or metastatic urothelial cancer, who had a PD-1 or PD-L1 inhibitor and platinum-based chemotherapy. The overall response rate was 44%, 12% having a complete response, and 32% having a partial response. The median duration of response was 7.6 months. A phase 3 trial to confirm the efficacy is underway.

Frequent adverse events observed were fatigue, peripheral neuropathy (nerve damage resulting in tingling or numbness), decreased appetite, rash, alopecia (hair loss), nausea, altered taste, diarrhea, dry eye, pruritis (itching) and dry skin.


FDA advised the health care profession to instruct patients to have contraceptives while receiving Padcev. FDA has granted accelerated approval for Padcev.


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