FDA Approves New Drug to Treat Advanced Bladder Cancer

Padcev™ (enfortumab vedotin-ejfv) has been approved by the U.S. Food and Drug Administration for people with bladder cancers that have not responded to chemotherapy or immunotherapy.1

Clinical trial results

Padcev was approved based on the results of a small clinical trial of 125 people with locally advanced or metastatic bladder cancer. Locally advanced means the cancer has become too large to be removed by surgery. Metastatic means the cancer cells have spread to other parts of the body.1

In the clinical trial, tumors shrank in 44 percent of people in the trial. Of those, 12 percent had a complete response, meaning the treatment was successful and all signs of the cancer disappeared, and 32 percent saw partial response, meaning the tumors shrank and/or didn't spread further.1

Which types of cells are affected by bladder cancer?

Bladder, or urothelial, cancer occurs in cells that line the bladder and nearby organs. These cells are also called transitional cells because they can change shape and stretch without breaking. Therefore, this cancer may also be called transitional cell cancer. More than 90 percent of bladder cancers begin in these cells.2

How does Padcev work?

Padcev targets specific cancer cells by locking onto the Nectin-4 molecule found in urothelial cancers. It is called a Nectin-4-directed antibody and microtubule inhibitor conjugate.

Dosing information

Padcev is delivered by intravenous infusion, or IV, over 30 minutes. This infusion should not be mixed with any other drugs. The recommended dose is 1.25 mg/kg, up to a maximum dose of 125 mg. This means the amount of Padcev you receive is based on your weight. Padcev is given on day 1, 8, and 15 of 28-day cycles.3

What are the possible side effects?

The most common side effects for people taking Padcev were:1

  • Fatigue
  • Peripheral neuropathy (nerve damage that causes tingling or numbness)
  • Decreased appetite
  • Rash
  • Hair loss
  • Nausea
  • Changes in taste
  • Diarrhea
  • Dry eye and vision changes
  • Itching
  • Dry skin

Some people experienced high blood sugar even if they did not have diabetes. Others had skin reactions were the drug was injected, including pain, blisters, and peeling skin.1 About half of those taking Padcev had a serious reaction.3

More safety information

Because of its impact on blood sugar levels and neuropathy (nerve pain), people taking Padcev should be watched closely. The amount of Padcev someone takes may need to be stopped or reduced if neuropathy gets worse or appears for the first time.1

Men and women should use contraception while taking Padcev and for some time after taking it. Women who are pregnant should not take the drug. Women who are nursing should not breastfeed while taking Padcev, and for 3 weeks after the last dose.1 People with moderate to severe liver damage should not take Padcev.1

Padcev is made by Astellas Pharma US Inc. Read the prescribing information to learn more.3

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