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AstraZeneca PLC on Friday said its drug Calquence, in combination with chemoimmunotherapy, has received approval from the US Food & Drug Administration for the treatment of adult patients with previously untreated mantle cell lymphoma who are ineligible for stem cell transplantation. The Cambridge, England-based pharmaceutical company said the approval, which followed a priority review, makes Calquence the first and only BTK inhibitor approved for first-line treatment of MCL in the US. The decision was based on data from the Echo phase III trial, which demonstrated that the Calquence combination reduced the risk of disease progression or death by 27% compared to standard chemoimmunotherapy. MCL is a rare and often aggressive form of non-Hodgkin lymphoma, often diagnosed in advanced stages. The Echo trial showed a median progression-free survival of 66.4 months for patients receiving the Calquence combination, compared to 49.6 months for those on standard therapy. After censoring for Covid-19-related deaths, the risk of progression or death was reduced by 36%. Dave Fredrickson, executive vice president of AstraZeneca’s Oncology Haematology business unit, said: ‘With today’s approval, Calquence provides a critical new treatment option to mantle cell lymphoma patients in the US, with Calquence proven to deliver nearly one and a half years of additional time without disease progression.’ The regulatory submission was reviewed under Project Orbis, a framework that allows concurrent evaluations of oncology medicines by international regulators. The combination therapy is also under review in Australia, Canada, and Switzerland, with applications pending in the EU, Japan, and other regions. Shares in AstraZeneca opened 1.0% up at 10,954.00 pence each in London on Friday. Copyright 2025 Alliance News Ltd. All Rights reserved.
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