FDA approves a drug pair given before bladder removal that cut the risk of death by 42% for bladder cancer patients who can’t take standard chemo

The Food and Drug Administration on Friday approved two cancer drugs, Imfinzi and Padcev, given together before surgery to remove the bladder, followed by Imfinzi alone afterward, for adults whose bladder cancer has grown into the bladder’s muscle wall and who can’t take or have refused cisplatin, a standard chemotherapy drug, the updated FDA label shows.

Who it helps

Cisplatin can harm the kidneys, and 76% of trial patients couldn’t take it, most often because of weak kidney function, the label and trial data show.  For them, the usual choice had been surgery alone.  Patients facing bladder removal can ask their cancer doctor whether the new regimen fits.  About 84,530 Americans will be diagnosed with bladder cancer this year, and blood in the urine is most often the first sign, the American Cancer Society says.

What the trial found

In the 695-patient VOLGA trial, 21% of the 233 people who got the drug pair died during follow-up, compared with 32% of the 229 who had surgery alone, a 42% lower risk of death.  The cancer came back, spread or caused death in 36% of the drug group versus 54% of the surgery group, the label says.  Patients got three three-week rounds of both drugs before surgery, then up to nine monthly doses of Imfinzi.

Imfinzi releases a brake that tumors use to hide from the immune system.  Padcev is an antibody-drug conjugate, an antibody that carries a cell-killing drug to cancer cells, the ASCO Post notes.  Common side effects included liver-test changes, low blood counts, rash and itching, according to Healio’s summary of the FDA notice.  AstraZeneca makes Imfinzi; Astellas and Pfizer make Padcev.  Prices were not in the records reviewed.

Source:  FDA prescribing information for Imfinzi, revised Nov. 13, 2026; Drugs@FDA, BLA 761069; ASCO Post, Nov. 13, 2026; Healio, Nov. 13, 2026; American Cancer Society.