Imfinzi gains positive EU opinion for bladder cancer

AstraZeneca PLC (LSE/STO/Nasdaq:LON:AZN) announced today that its drug Imfinzi (durvalumab) has been recommended for approval in the European Union (EU) as a treatment for adult patients with muscle-invasive bladder cancer (MIBC) in combination with chemotherapy. This recommendation from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency is based on the results from the NIAGARA Phase III trial.

The NIAGARA trial, which was presented at the 2024 European Society for Medical (TASE:BLWV) Oncology (ESMO) Congress and published in The New England Journal of Medicine, showed that Imfinzi, in combination with gemcitabine and cisplatin, followed by Imfinzi as monotherapy after surgery, reduced the risk of disease recurrence by 32% and decreased the risk of death by 25% compared to chemotherapy alone.

Dr. Michiel Van der Heijden, a medical oncologist involved in the trial, highlighted the significance of the recommendation, noting the potential to transform the treatment approach for patients across Europe. Susan Galbraith, Executive Vice President of Oncology R&D at AstraZeneca (NASDAQ:AZN), echoed this sentiment, stating that the trial results support AstraZeneca’s strategy of introducing innovative medicines at earlier disease stages.

Imfinzi has been approved in the US and other countries for the same indication based on the NIAGARA results, with regulatory applications under review in Japan and several other countries. The drug is part of AstraZeneca’s extensive portfolio and is being tested for various cancers as a single treatment and in combination with other therapies.

The company is dedicated to providing new treatment options for cancer patients and is focused on bringing immunotherapy-based treatments to new settings across a range of cancer types. AstraZeneca’s ultimate vision is to redefine cancer care and eliminate cancer as a cause of death. This recommendation is a step towards achieving that goal, offering a new potential standard of care for patients with muscle-invasive bladder cancer in Europe.

This news is based on a press release statement and reflects the company’s commitment to advancing cancer treatment through innovative research and development.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.