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AstraZeneca PLC on Monday detailed progress with two of its drugs as it reported an endorsement in the EU and an approval in the US. The Cambridge, England-based pharmaceuticals firm said Imfinzi, or durvalumab, has been approved in the US by the Food & Drug Administration as a combination treatment for muscle-invasive bladder cancer in adult patients. This approval came after the results from its Niagara Phase 3 trial showed a 32% reduction in risk of recurrence and a 25% cut to the risk of death when compared to neoadjuvant chemotherapy alone. The trial saw patients undergo four cycles of Imfinzi in combination with neoadjuvant chemotherapy before radical cystectomy. This was then followed by 8 cycles of Imfinzi monotherapy, or neoadjuvant chemotherapy before radical cystectomy, said AstraZeneca. AstraZeneca added that it has been approved in the US as the first and only immunotherapy for patients with muscle-invasive bladder cancer. Bladder Cancer Advocacy Network Chief Executive Meri-Margaret Deoudes said: ‘More than 20,000 people in the US were treated for muscle-invasive bladder cancer last year and there is a significant need for new treatment options that improve patient outcomes. The approval of the durvalumab perioperative regimen is welcome news, transforming how clinicians will tackle this disease in future and offering new hope to patients and their loved ones.’ Shares in AstraZeneca were down 1.3% at 11,264.00 pence on Monday morning in London. Additionally, the European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended Calquence for approval in the EU as a combination treatment for some adult patients with previously untreated mantle cell lymphoma, a blood cancer. AstraZeneca said the backing was based upon the results of its Echo Phase 3 trial demonstrating over 16 months of progression-free survival improvement versus chemotherapy alone. AstraZeneca noted that this recommendation follows the CHMP’s positive opinion adopted in February for Calquence, or acalabrutinib, as a monotherapy for treatment of adult patients with relapsed or refractory MCL. AstraZeneca Executive Vice President Susan Galbraith commented: ‘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. ‘If approved, Calquence has the potential to transform the standard of care as the first BTK inhibitor approved for these patients in Europe.’ Copyright 2025 Alliance News Ltd. All Rights Reserved.
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