FDA Approves Padcev-Keytruda Combo in Advanced Bladder Cancer

The FDA approves the Padcev-Keytruda treatment combination for patients with locally advanced or metastatic bladder cancer.

The Food and Drug Administration (FDA) has approved Padcev (enfortumab vedotin-ejfv) plus Ketruda (pembrolizumab) for patients with locally advanced or metastatic bladder cancer. Alongside this, the FDA previously granted an accelerated approval for this patient population who are unable to be treated with cisplatin-containing chemotherapy.

The recent EV-302/KN-A39 trial included 886 patients with locally advanced bladder cancer and no prior systemic therapy. Patients were randomly selected to be placed into the Padcev plus Keytruda group or the platinum-based chemotherapy group. Patients were randomized based on eligibility for cisplatin, PD-L1 expression and present liver metastases.

Patients in the Padcev plus Keytruda group were given a dose of 1.25 milligrams, with a 3o-minute infusion on Days 1 and 8 throughout a 21-day cycle.

When Keytruda is administered with Padcev, the average dose is 200 milligrams, with an infusion every three weeks or 400 milligrams every six weeks.

The study aimed to focus on overall survival (OS; the time from treatment to death, regardless of disease recurrence) and progression-free survival (PFS; length of time during and after the treatment of a disease that a patient lives with the disease, without worsening).

Both OS and PFS showed significant improvements when the Padcev plus Keytruda group was being studied. The median for OS was 31.5 months, while the chemotherapy group was 16.1 months. Regarding PFS, the median was 12.5 months for the Padcev-Keytruda combination group and 6.3 months in the chemotherapy group.

Treatment-related side effects in the Padcev plus Keytruda group showed increased aspartate aminotransferase (an enzyme commonly found in the liver), increased creatinine (waste product from digestion of protein), rash, high blood sugar, peripheral neuropathy (weakness and numbness in hands and feet) and increased lipase (enzymes that break down fats in food).

Additional side effects may include decreased lymphocytes (white blood cells), increased alanine aminotransferase (an enzyme commonly found in the liver), decreased hemoglobin (protein in red blood cells), fatigue, decreased sodium, decreased phosphate, itchy skin, diarrhea, hair loss, decreased weight, decreased appetite, increased urate, decreased neutrophils, decreased potassium, dry eye, nausea, constipation, increased potassium, dysgeusia (altered taste), urinary tract infection and decreased platelets.

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