AstraZeneca’s Imfinzi has officially been approved in the European Union for the treatment of muscle-invasive bladder cancer in adults.
The new approval allows Imfinzi to be used alongside gemcitabine and cisplatin before surgery, followed by Imfinzi alone after surgery—a combo that now becomes the first and only perioperative immunotherapy for this brutal cancer type.
The decision was based on positive results from AstraZeneca’s Niagara Phase III trial, which showed statistically significant improvements in event-free survival, because apparently just surviving isn’t enough anymore.
More than 35,000 people in Europe were treated for this aggressive form of bladder cancer last year, and many still had to deal with the cancer coming back for round two.
Despite AstraZeneca declaring this a “standard of care” revolution, its shares dipped 0.6% in early London trading—because the market, unlike the trial results, remains unimpressed.
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