Astrazeneca's Imfinzi receives green light from US FDA.
Drugmaker Astrazeneca said on Friday that Imfinzi has been approved in the US as part of the first immunotherapy‑based combination for patients with high‑risk, non‑muscle‑invasive bladder cancer who have not previously been treated with Bacillus Calmette-Guérin.
Source: Sharecast
Astrazeneca said the Food and Drug Administration's decision was based on results from its Phase III POTOMAC trial, which showed that adding a year of Imfinzi to standard BCG therapy cut the risk of high‑risk disease returning, progressing or leading to death by 32% after one year compared with BCG alone.
The FTSE 100-listed firm said the combination's safety profile was consistent with existing treatments, with no new concerns identified, no impact on patients' ability to complete BCG therapy and no meaningful change in reported quality of life.
Astrazeneca's Dave Fredrickson said: "Today's approval for Imfinzi brings the first immunotherapy combination regimen to patients in the US with BCG-naïve, high-risk non-muscle-invasive bladder cancer, an early setting that builds on the positive impact Imfinzi is already having in muscle-invasive disease.
"The early and sustained disease-free survival benefit demonstrated by Imfinzi plus BCG in the POTOMAC trial is an important advance for patients at risk of early disease recurrence and signals a shift in the standard of care."
As of 0820 BST, Astrazeneca shares were up 0.96% at 13,868p.
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