FDA approves Padcev for urothelial cancer
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The FDA granted accelerated approval to enfortumab vedotin-ejfv for treatment of adults with locally advanced or metastatic urothelial cancer, the agent’s developers announced in a press release.
The approval applies to use of enfortumab vedotin-ejfv (Padcev; Astellas, Seattle Genetics) by patients who previously received a PD-1/PD-L1 inhibitor and a platinum-containing chemotherapy before or after surgery in a locally advanced or metastatic setting.
“Metastatic urothelial cancer is an aggressive and devastating disease with limited treatment options, and the approval of Padcev is a significant advance for these patients who previously had limited options after initial therapies failed,” Jonathan E. Rosenberg, MD, medical oncologist and chief of the genitourinary medical oncology service at Memorial Sloan Kettering Cancer Center, said in the release.
Enfortumab vedotin-ejfv is a first-in-class antibody-drug conjugate directed against nectin-4, a protein highly expressed in urothelial cancers.
The single-arm, phase 2 EV-201 trial evaluated the agent among 125 patients with locally advanced or metastatic urothelial cancer who underwent prior treatment with a PD-1 or PD-L1 inhibitor and a platinum-based chemotherapy.
The trial enrolled a range of patients with difficult-to-treat cancers, including those whose disease had spread to the liver.
Patients received 1.25 mg/kg enfortumab vedotin-ejfv on days 1, 8 and 15 of each 28-day cycle.
Overall response rate by blinded independent central review — the study’s primary endpoint — was 44% (95% CI, 35.1-53.2).
Fifteen patients (12%) achieved complete response and 40 (32%) achieved partial response. Median duration of response was 7.6 months (95% CI, 6.3-not estimable).
The most common adverse reactions included fatigue (56%), peripheral neuropathy (56%), decreased appetite (52%), rash (52%), alopecia (50%), nausea (45%), dysgeusia (42%), diarrhea (42%), dry eye (40%), pruritus (26%) and dry skin (26%). The most common grade 3 or higher adverse reactions included rash (13%), diarrhea (6%) and fatigue (6%).
The most common serious adverse reactions included urinary tract infection (6%), cellulitis (5%), febrile neutropenia (4%), diarrhea (4%), sepsis (3%), acute kidney injury (3%), dyspnea (3%) and rash (3%).
Six percent of patients discontinued treatment due to peripheral neuropathy.
“The FDA approval of Padcev is welcome news for patients with bladder cancer,” Andrea Maddox-Smith, CEO of Bladder Cancer Advocacy Network, said in the release. “Though new medicines for bladder cancer have been approved in recent years, most people living with advanced stages of this disease face a difficult journey with few treatment options.”