3rd Oct 2024 11:01
(Alliance News) - AstraZeneca PLC on Thursday said its cancer treatment Calquence obtained priority review by the US Food & Drug Administration for a form of lymphoma.
The Cambridge, England-based pharmaceutical company said the priority review for its supplemental new drug application for Calquence is for adults with untreated mantle cell lymphoma.
The review is based on results from a phase 3 trial, which showed that Calquence plus bendamustine and rituximab reduced the risk of disease progression or death by 27% compared to standard-of-care chemoimmunotherapy.
Mantle cell lymphoma is a rare and typically aggressive form of non-Hodgkin lymphoma.
AstraZeneca said that if approved, it would mark "significant improvements over available options".
The company expects a regulatory decision by the FDA during the first quarter of 2025.
Susan Galbraith, executive vice president, Oncology research & development at AstraZeneca said: "Today's priority review acceptance reinforces the potential of Calquence to transform outcomes in untreated mantle cell lymphoma. Data from the ECHO trial showed Calquence plus chemoimmunotherapy significantly delayed disease progression and showed a trend to improved survival in patients with this currently incurable blood cancer. We are working closely with the FDA to provide patients this potential new treatment as soon as possible."
AstraZeneca shares were 0.6% higher at 12,020.00 pence each on Thursday morning in London.
By Tom Budszus, Alliance News slot editor
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