AstraZeneca’s Imfinzi recommended for EU approval in lung cancer

UK – AstraZeneca’s Imfinzi (durvalumab) has been recommended for approval by the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for the treatment of limited-stage small cell lung cancer (LS-SCLC) in the European Union (EU).

Imfinzi, when used alone, is now being considered as a treatment option for adults whose LS-SCLC has not advanced after they have undergone platinum-based chemoradiation therapy.

This recommendation follows the promising results of the Phase III ADRIATIC trial, which showed that Imfinzi reduced the risk of death by 27% compared to a placebo.

Additionally, the therapy demonstrated a 24% reduction in disease progression or death risk, further reinforcing its potential benefits.

Imfinzi’s safety profile was also found to be generally manageable and consistent with its known characteristics, with no new safety concerns emerging from the trial.

 This reassuring safety data adds confidence to the treatment’s profile in the EU.

Based on the same positive ADRIATIC trial findings, Imfinzi has already received approval in the United States and several other countries.

Ongoing regulatory reviews for the same indication are currently underway in Japan and other countries.

The ADRIATIC trial involved 164 clinical centers in 19 countries in Europe, Asia, North America, and South America, highlighting its international scope and the therapy’s wide-reaching potential.

The trial compared Imfinzi, both as a standalone treatment and in combination with another therapy, Imjudo (tremelimumab), to a placebo in patients whose LS-SCLC had not progressed following chemoradiation therapy.

This approach is part of AstraZeneca’s broader commitment to advancing cancer treatments.

Susan Galbraith, Executive Vice President of Oncology R&D at AstraZeneca, expressed optimism about Imfinzi’s potential. She stated that the drug could change the treatment landscape for LS-SCLC patients.

She highlighted the fact that, at the three-year mark in the ADRIATIC trial, 57% of patients were still alive, suggesting that Imfinzi could offer a new, life-extending treatment option for these patients.

If approved, this would mark the first time these individuals could access immunotherapy, potentially reshaping survival expectations for this patient group.

Imfinzi is part of a larger development program being tested both alone and in combination with other therapies for various types of cancer.

AstraZeneca’s commitment to advancing lung cancer treatments is evident in its previous successes, including approving its other lung cancer therapies, Tagrisso and Imfinzi, which were recommended for use within the NHS in England and Wales. 

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