FDA Grants Accelerated Approval to Combination Treatment for Patients with Advanced or Metastatic Urothelial Carcinoma


According to reporting for Cure Today, the FDA recently granted Accelerated Approval to a combination treatment of Padcev (enfortumab vedotin-ejfv) and Keytruda (pembrolizumab) for advanced or metastatic urothelial carcinoma. The Accelerated Approval program was initiated in 1992 with a goal of more quickly approving treatments to fill unmet medical needs. In this case, there are thousands of people living within the country who cannot receive chemotherapy that contains cisplatin. These patients lacked effective or accessible therapeutic options. Thus, the approval of Padcev-Keytruda has the potential to fulfill these patient needs and contribute to better outcomes.

This approval hinged on data from the EV-103/KEYNOTE-869 trial. Altogether, 121 participants enrolled. Within the trial, patients were split into two cohorts. One cohort received only Padcev, while the second cohort received the combination therapy. The study found that 68% of participants had a treatment response when taking the Padcev-Keytruda combination (12% had a complete response and 56% had a partial response). Some patients also saw durable and sustained responses, lasting up to 46 months (3 years and 10 months). While the combination treatment was found to be safe and well-tolerated, some individuals did experience adverse reactions to treatment. These included appetite loss, itchiness, a distorted sense of taste, rashes, fatigue, dry eyes, dizziness, and urinary tract infections, among others.

Urothelial Carcinoma

Also referred to as bladder cancer, urothelial carcinoma begins in the urothelium, which is the tissue that lines part of the urinary system: the urethra, bladder, ureters, and renal pelvis. Doctors aren’t exactly sure what causes this cancer. However, there are known risk factors, such as:

  • Smoking cigarettes
  • Certain medication use
  • Arsenic in drinking water
  • Older age
  • Being Caucasian
  • Chronic bladder infections
  • Being male
  • Having a personal history of bladder cancer
  • Chemical exposure

In early stages of this cancer, those affected may not experience any symptoms. As symptoms appear, they may include:

  • Fatigue and general weakness
  • Hematuria (blood in the urine)
  • Appetite loss
  • Low-grade fever
  • Unintentional weight loss
  • Changes in urinary urgency and frequency
  • Painful urination
  • A lump or mass in the kidney area
  • Pain on one side in the lower back
  • Bone pain
  • Swollen feet

In many cases, people visit their doctors after noticing blood in their urine. This leads to additional testing and examinations to identify and diagnose this cancer. Once diagnosed, doctors can begin prescribing treatments. Immunotherapy, targeted therapy, surgery, radiation, intravesical therapy, and chemotherapy are all treatment options for this indication.

Jessica Lynn

Jessica Lynn

Jessica Lynn has an educational background in writing and marketing. She firmly believes in the power of writing in amplifying voices, and looks forward to doing so for the rare disease community.

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