WILMINGTON, Del. - The U.S. Food and Drug Administration (FDA) has granted approval to AstraZeneca (NASDAQ:AZN)'s CALQUENCE® (acalabrutinib) in combination with bendamustine and rituximab for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL) who are ineligible for autologous hematopoietic stem cell transplantation. The approval marks another milestone for AstraZeneca, a $207.75 billion market cap pharmaceutical giant with an impressive 82.61% gross profit margin. According to InvestingPro analysis, the company maintains a GREAT financial health score, positioning it well for continued growth in the pharmaceutical sector. This marks the first time a Bruton tyrosine kinase (BTK) inhibitor has been approved for the 1st-line treatment of MCL in the United States.
The decision followed a Priority Review of findings from the ECHO Phase III trial, which demonstrated a significant improvement in progression-free survival (PFS) when compared to standard chemoimmunotherapy. Specifically, the trial showed that CALQUENCE combined with bendamustine and rituximab reduced the risk of disease progression or death by 27%, with a median PFS of 66.4 months versus 49.6 months for the standard treatment.
MCL, a rare and aggressive form of non-Hodgkin lymphoma, affects over 21,000 patients across the US, UK, France, Germany, Spain, Italy, Japan, and China. The approval is particularly significant for older patients with MCL, as highlighted by Dr. Michael Wang, the principal investigator in the trial.
The safety profile of CALQUENCE was consistent with previous findings, showing no new safety signals. The full approval for CALQUENCE also converts its accelerated approval from October 2017 for adult patients with MCL treated with at least one prior therapy. This development adds to AstraZeneca's strong performance, with the company reporting 13.81% revenue growth in the last twelve months. InvestingPro data reveals 8 additional key insights about AstraZeneca's financial health and market position, available to subscribers.
In addition to the U.S., CALQUENCE is under review by regulatory authorities in Australia, Canada, and Switzerland, and applications are also being reviewed in the EU, Japan, and other countries based on the ECHO trial results.
AstraZeneca's commitment to advancing care in hematology is evident in its extensive clinical development program for CALQUENCE, which is being evaluated across multiple B-cell blood cancers.
This news is based on a press release statement from AstraZeneca. For comprehensive analysis of AstraZeneca's financial outlook and detailed metrics, investors can access the full Pro Research Report, available exclusively on InvestingPro, which provides deep-dive analysis of this prominent pharmaceutical player's market position and growth potential.
In other recent news, AstraZeneca reported its total voting rights, a critical disclosure for shareholders. The company has also seen significant developments in its pharmaceutical portfolio. The European Union approved AstraZeneca's oncology medication Tagrisso for the treatment of a specific type of lung cancer, marking a significant advancement. However, AstraZeneca and its partner Daiichi Sankyo withdrew their application for marketing authorization in the European Union for their drug datopotamab deruxtecan, intended to treat a form of lung cancer. Despite this, the companies remain committed to the drug's development.
TD Cowen raised concerns about the global pharmaceutical industry's future due to the impact of U.S. tariffs, geopolitical tensions, and the unpredictable responses from foreign governments. The analysis indicates that large-cap pharma companies, such as AstraZeneca, are well-positioned to mitigate these risks. Furthermore, AstraZeneca announced the appointment of Rene Haas and Birgit Conix as Non-Executive Directors as part of the company's ongoing board refreshment process. These recent developments highlight AstraZeneca's continuous efforts in the pharmaceutical industry.
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