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The to enfortumab vedotin (Padcev) and pembrolizumab (Keytruda) as first-line treatment for certain patients with locally advanced or metastatic urothelial cancer, the agency announced on Monday.

Specifically, the combination is indicated for those who are ineligible for cisplatin-containing chemotherapy, and the approval marks the first anti-PD-1/antibody-drug conjugate combination for this patient population.

Approval was based on results from 121 patients in cohort K, , and the dose-escalation cohort of the /KEYNOTE-869 trial.

At a median follow-up of 44.7 months for the dose-escalation and A cohorts and 14.8 months for the K cohort, enfortumab vedotin plus pembrolizumab demonstrated an objective response rate of 68% (95% CI 58.7-76.0), with complete responses in 12%.

Median duration of response was 22.1 months for the dose-escalation and A cohorts and not reached for cohort K.

"The accelerated approval for the combination of Padcev and pembrolizumab marks an important milestone for the approximately 8,000 to 9,000 patients in the United States with locally advanced or metastatic urothelial cancer who are not eligible for cisplatin-containing chemotherapy," said Ahsan Arozullah, MD, MPH, head of oncology development at Astellas, in a from the drugmaker.

Continued approval is contingent upon results of the ongoing confirmatory .

Common adverse events (AEs) with the combination included rash (71% of patients), peripheral neuropathy (65%), fatigue (60%), alopecia (52%), weight loss (48%), diarrhea (45%), pruritus (40%), reductions in appetite (38%), nausea (36%), dysgeusia (35%), urinary tract infections (30%), constipation (27%), peripheral edema (26%), dry eye (25%), dizziness (23%), arthralgia (23%), and dry skin (21%).

Laboratory abnormalities included increases in glucose (74%), aspartate aminotransferase (73%), creatinine (69%), alanine aminotransferase (60%), lipase (59%), potassium (27%), and calcium (27%); and decreases in hemoglobin (69%), lymphocytes (64%), sodium (60%), albumin (59%), phosphate (51%), potassium (35%), and neutrophils (32%).

The recommended dose of enfortumab vedotin when given with pembrolizumab is 1.25 mg/kg (up to a maximum of 125 mg for patients ≥100 kg) administered on days 1 and 8 of a 21-day cycle until disease progression or unacceptable toxicity. The recommended pembrolizumab dose, administered after enfortumab vedotin on the same day, is 200 mg every 3 weeks or 400 mg every 6 weeks until disease progression, unacceptable toxicity, or up to 24 months.

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