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OBR OncologyNew Frontline Standard for Urothelial Carcinoma Comes With Questions

Unresolved Concerns Surround Accelerated Approval of EV Plus Pembrolizumab for Urothelial Carcinoma

The recent FDA accelerated approval of enfortumab vedotin (EV) in combination with pembrolizumab for cisplatin-ineligible patients with metastatic urothelial carcinoma (UC) has stirred both optimism and caution within the medical community. Although the treatment offers a new option for a patient group with limited choices, questions about optimal duration, cost, and adverse effects remain.

Key Points:
  • FDA granted accelerated approval for EV plus pembrolizumab for cisplatin-ineligible patients with metastatic UC.
  • Clinical objective response rate (ORR) of 64.5% observed in combination therapy, compared to 45.3% in EV monotherapy.
  • Median overall survival (OS) of 22.3 months in combination group, compared to 21.7 months in EV-alone group.
  • Neuropathy occurred in 60.5% of patients on combination therapy; treatment was discontinued in 25% and 19% of patients in the combination and EV-alone groups, respectively.
Additional Points:
  • Cost of one cycle of EV plus pembrolizumab is approximately $45,000 per three-week cycle.
  • Ongoing shortage of several cancer drugs, including carboplatin, has led to increased use of the new combination therapy.
  • Further research is needed to determine long-term efficacy and safety.
  • Although the accelerated approval of EV plus pembrolizumab offers a promising new treatment avenue for cisplatin-ineligible UC patients, unresolved issues such as treatment duration, cost, and adverse effects necessitate further investigation.
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“Do you really need to give the enfortumab and then subject somebody to neuropathy? Because once the neuropathy happens, it’s hard to get rid of.”
– Daniel P. Petrylak, MD, of the Yale Cancer Center in New Haven, Connecticut

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