Imfinzi Combination Snags FDA Approval for High-Risk Non-Muscle Invasive Bladder Cancer
The combination cut recurrence, progression or death risk by 32% in the POTOMAC trial and adds a new option beyond BCG alone.
- On Thursday, the Food and Drug Administration approved AstraZeneca's immunotherapy Imfinzi in combination with Bacillus Calmette-Guérin for patients with BCG-naive, high-risk non-muscle-invasive bladder cancer .
- High-Risk NMIBC patients face significant challenges, with over 31,000 individuals treated annually in the US experiencing frequent recurrence, progression, or bladder removal, creating urgent demand for effective alternatives to standard surgery and BCG alone.
- The POTOMAC trial enrolled over 1,000 patients and demonstrated a 32% reduction in disease recurrence, progression, or death risk. Principal investigator Neal Shore of the Carolina Urologic Research Centre called it the "first advance" in high-risk NMIBC care in over three decades.
- AstraZeneca views bladder cancer as a major commercial opportunity for Imfinzi, which saw first-quarter sales leap 30% to $1.7 billion this year, with the disease now a key driver for the company's growth.
- The bladder cancer treatment market remains increasingly competitive, with rivals including MSD's Keytruda, ImmunityBio's Anktiva, Ferring's Adstiladrin, and Johnson & Johnson's Inlexzo. AstraZeneca recently reported positive VOLGA trial results in muscle-invasive bladder cancer, signaling further portfolio expansion.
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Medical Daily
Health Journal OnlineFDA Approves New Immunotherapy Combination for High-Risk Early-Stage Bladder Cancer
The U.S. Food and Drug Administration (FDA) has approved a new treatment option for patients with high-risk non–muscle invasive bladder cancer (NMIBC), authorizing the use of durvalumab (Imfinzi) in combination with Bacillus Calmette-Guérin (BCG) on May 28, 2026.
FDA OKs Immunotherapy-BCG Combo for High-Risk Bladder Cancer
(MedPage Today) -- The FDA approved durvalumab (Imfinzi) in combination with bacillus Calmette-Guérin (BCG) for adults with BCG-naive, high-risk non-muscle-invasive bladder cancer (NMIBC). The approval was based on results from the phase...
Imfinzi combination snags FDA approval for high-risk non-muscle invasive bladder cancer
The FDA has approved an immunotherapy combination therapy for adult patients with Bacillus Calmette-Guérin-naive, high-risk non-muscle invasive bladder cancer.The combination of durvalumab (Imfinzi, AstraZeneca) plus Bacillus Calmette-Guérin (BCG) is the first of its kind to be approved for this patient population, according to a manufacturer-issued press release.
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