AstraZeneca makes regulatory progress with Imfinzi, Calquence

(Sharecast News) - AstraZeneca announced on Monday that it secured a US regulatory approval and a positive EU recommendation for two of its oncology therapies, Imfinzi and Calquence, marking progress in its immunotherapy and haematology pipelines. The FTSE 100 pharmaceutical giant said the US Food and Drug Administration (FDA) has approved 'Imfinzi', or durvalumab, as the first perioperative immunotherapy for adults with muscle-invasive bladder cancer (MIBC).

It said the approval covered a treatment regimen combining Imfinzi with gemcitabine and cisplatin before surgery, followed by Imfinzi as adjuvant monotherapy post-surgery.

The approval was based on results from the phase three NIAGARA trial, which showed a 32% reduction in the risk of disease recurrence and a 25% reduction in the risk of death compared with neoadjuvant chemotherapy alone.

The findings were presented at the 2024 ESMO Congress and published in the New England Journal of Medicine.

AstraZeneca said MIBC affects more than 20,000 people annually in the US and was associated with high recurrence rates even after surgery.

"Today's approval for Imfinzi represents a paradigm shift, bringing the first perioperative immunotherapy to patients in the US with muscle-invasive bladder cancer and addressing a significant need for better treatment options," said Dave Fredrickson, executive vice-president of AstraZeneca's oncology haematology business unit.

"The NIAGARA trial showed more than 80% of patients were still alive at two years, underscoring the potential of this innovative perioperative regimen to become a new standard of care in this setting."

Separately, the European Medicines Agency's Committee for Medicinal Products for Human Use issued a positive opinion recommending approval of 'Calquence', or acalabrutinib, in combination with bendamustine and rituximab as a first-line treatment for adult patients with mantle cell lymphoma (MCL) who were not eligible for stem cell transplantation.

The recommendation was based on the phase three ECHO trial, which demonstrated a 27% reduction in the risk of progression or death compared to standard chemoimmunotherapy. Median progression-free survival was 66.4 months for the Calquence combination, versus 49.6 months with chemoimmunotherapy alone.

AstraZeneca said the latest recommendation followed a recent CHMP opinion backing Calquence monotherapy for relapsed or refractory MCL.

"Today's positive recommendation from the CHMP further reinforces the potential of Calquence to advance first-line treatment options in mantle cell lymphoma, with the Calquence combination demonstrating an almost one and a half year improvement in progression-free survival in this setting," said Susan Galbraith, executive vice-president of oncology haematology research and development.

"If approved, Calquence has the potential to transform the standard of care as the first BTK inhibitor approved for these patients in Europe."

Reporting by Josh White for Sharecast.com.