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July 9, 2021Padcev Receives Full Approval and New Indication to Treat Urothelial Cancer
July 9, 2021 – The U.S. FDA has approved a new indication for Padcev® (enfortumab vedotin-ejfv), manufactured by Seagen. The drug is now indicated to treat adults who have locally advanced or metastatic urothelial cancer, are ineligible for cisplatin-containing chemotherapy, and have previously received one or more prior lines of therapy.
The FDA has also converted conditional approval for Padcev’s original indication into full approval. The drug was granted conditional approval in 2019 to treat locally advanced or metastatic urothelial cancer in adults who have previously received a PD-1 or PD-L1 inhibitor and platinum-containing chemotherapy.
Urothelial cancer is cancer that begins in the urothelial cells linking the bladder, urethra, and other organs. It is also known as transitional cell cancer, as urothelial cells are known as transitional cells that can change shape and stretch without breaking. It’s one of the most common forms of bladder cancer, and while it’s highly treatable in early stages, patients who have advanced disease may have few options. About half of all patients diagnosed with advanced bladder cancer are unable to receive cisplatin-based treatment.
In a clinical study, patients previously treated with platinum-based chemotherapy and a PD-1/L1 inhibitor who received Padcev lived a median of 3.9 months longer than patients treated with chemotherapy. An additional clinical trial that enrolled patients who were ineligible for cisplatin-containing chemotherapy saw Padcev deliver a 51% objective response rate and a median duration of response of 13.8 months.
Recommended dosing is 1.25mg/kg of the patient’s body weight, up to a maximum dose of 125mg, given via 30-minute intravenous infusion on Days 1, 8, and 15 of a 28-day cycle until disease progression or unacceptable toxicity occur. A black box warning cautions that Padcev can cause severe and fatal cutaneous adverse reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis that may require referral to specialized care.