Today, AstraZeneca PLC (LSE/STO/Nasdaq: LON:AZN), a pharmaceutical giant with a market capitalization of $207.67 billion and impressive gross profit margins of 82.61%, announced that its drug Calquence (acalabrutinib), in combination with bendamustine and rituximab, has received approval from the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL) who are ineligible for autologous hematopoietic stem cell transplantation.
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This FDA decision, which followed a Priority Review designation, was based on the outcomes of the ECHO Phase III trial presented at the European Hematology Association 2024 Congress. The trial demonstrated that the Calquence combination offered a significant improvement in progression-free survival (PFS) over chemoimmunotherapy alone, extending PFS by more than 16 months.
MCL is a rare, often aggressive type of non-Hodgkin lymphoma, with more than 21,000 patients diagnosed across key global markets, including the US, UK, France, Germany, Spain, Italy, Japan, and China. The approval marks Calquence as the first and only BTK inhibitor approved for first-line treatment of MCL in the United States.
Dr. Michael Wang, the principal investigator of the trial, emphasized the importance of balancing efficacy and tolerability in treating MCL, particularly in elderly patients. He noted that the trial’s results support the potential of the acalabrutinib combination to set a new standard of care for this patient population.
Dave Fredrickson of AstraZeneca highlighted that the approval of Calquence provides nearly one and a half years of additional disease progression-free time for patients, affirming its potential as a foundational therapy across multiple blood cancers.
The ECHO trial, which enrolled patients during the COVID-19 pandemic, showed that the Calquence combination reduced the risk of disease progression or death by 27% compared to standard chemoimmunotherapy. The median PFS was 66.4 months for the Calquence group versus 49.6 months for chemoimmunotherapy alone.
The trial’s safety and tolerability profile for Calquence was consistent with its known safety profile, and no new safety signals were identified. With revenue growth of 13.81% in the last twelve months and strong financial health metrics, InvestingPro data reveals AstraZeneca’s robust position to capitalize on this expansion of Calquence’s market potential. Get access to 8 more exclusive ProTips and comprehensive financial analysis with an InvestingPro subscription.
Moreover, this approval converts the accelerated approval of Calquence for adult patients with MCL who have received at least one prior therapy, initially granted by the FDA in October 2017, to a full approval.
AstraZeneca’s Calquence is also under review by regulatory authorities in Australia, Canada, Switzerland, the EU, Japan, and other countries based on the ECHO trial results. The drug is part of AstraZeneca’s extensive clinical development program, aiming to evaluate it as a single treatment and in combination with other therapies for various B-cell blood cancers.
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This news is based on a press release statement from AstraZeneca and the recent SEC filing.
In other recent news, AstraZeneca received FDA approval for CALQUENCE, a new treatment for adult patients with untreated mantle cell lymphoma. This approval followed a Priority Review of the ECHO Phase III trial results, which showed significant improvement in progression-free survival.
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