WILMINGTON, Del. - AstraZeneca (NASDAQ:AZN)'s supplemental New Drug Application (sNDA) for CALQUENCE (acalabrutinib) has been accepted for Priority Review by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL), a rare and aggressive form of non-Hodgkin lymphoma.
The FDA's Priority Review status accelerates the review time for drugs that may offer significant improvements in treatment safety or efficacy. The anticipated FDA decision date is set for the first quarter of 2025.
The application is supported by results from the ECHO Phase III trial, which demonstrated that a combination regimen including CALQUENCE reduced the risk of disease progression or death by 27% compared to standard-of-care chemoimmunotherapy. In the trial, the CALQUENCE combination also extended median progression-free survival by almost 1.5 years.
Susan Galbraith, Executive Vice President, Oncology R&D at AstraZeneca, stated that the Priority Review acceptance "reinforces the potential of CALQUENCE to transform outcomes in untreated mantle cell lymphoma."
The sNDA is being reviewed under Project Orbis, an initiative aiming to expedite the availability of cancer treatments globally.
The ECHO trial, conducted across 27 countries, assessed the efficacy and safety of CALQUENCE in combination with bendamustine and rituximab compared to standard chemoimmunotherapy in patients 65 years or older with previously untreated MCL. The primary endpoint was progression-free survival (PFS), with overall survival (OS) as a key secondary endpoint.
While the OS data from the trial are not yet mature, there has been a favorable trend observed for the CALQUENCE combination. The safety profile of CALQUENCE in the trial was consistent with its known safety profile, with no new safety signals identified.
Currently, CALQUENCE is indicated for the treatment of adult patients with MCL who have received at least one prior therapy, and for the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
This information is based on a press release statement from AstraZeneca.
In other recent news, AstraZeneca and Arcus Biosciences (NYSE:RCUS) have partnered to evaluate a new combination therapy for clear cell renal cell carcinoma, a common form of kidney cancer. The collaboration will explore the potential of Arcus's investigational HIF-2a inhibitor, casdatifan, in conjunction with AstraZeneca's investigational PD-1/CTLA-4 bispecific antibody, volrustomig. In other developments, AstraZeneca's ENHERTU, developed with Daiichi Sankyo, has received FDA Priority Review based on results from the DESTINY-Breast06 Phase III trial. Meanwhile, the company's TAGRISSO gained FDA approval for the treatment of Stage III epidermal growth factor receptor-mutated non-small cell lung cancer, based on the LAURA Phase III trial. The FDA also approved AstraZeneca's FluMist influenza vaccine for self-administration at home and Fasenra for the treatment of adult patients with a rare immune-mediated vasculitis. However, AstraZeneca faced challenges with two of its potential drugs failing to demonstrate effectiveness in treating lung and breast cancer. These setbacks led to Erste Group revising its rating for AstraZeneca from Buy to Hold, while Deutsche Bank, BMO Capital, TD Cowen, and BofA Securities maintained positive outlooks. These are recent developments in AstraZeneca's ongoing advancements.
InvestingPro Insights
AstraZeneca's recent FDA Priority Review acceptance for CALQUENCE aligns with the company's strong market position and growth prospects. According to InvestingPro data, AstraZeneca boasts a substantial market capitalization of $244.75 billion, reflecting its prominence in the pharmaceutical industry. The company's revenue growth of 10.45% over the last twelve months and 13.33% in the most recent quarter underscores its ability to expand its product portfolio and market reach.
InvestingPro Tips highlight AstraZeneca's financial strength and market position. The company is expected to see net income growth this year, which could be further bolstered by potential approvals like CALQUENCE for untreated mantle cell lymphoma. Additionally, AstraZeneca's status as a "prominent player in the Pharmaceuticals industry" is evident in its robust pipeline and ongoing research and development efforts.
The company's commitment to shareholder value is demonstrated by its 32-year streak of maintaining dividend payments, as noted in the InvestingPro Tips. This long-standing dividend history, coupled with a current dividend yield of 1.23%, may appeal to income-focused investors.
It's worth noting that AstraZeneca trades at a relatively high P/E ratio of 37.9, which could be justified by its growth prospects and potential market expansions, such as the one highlighted in this article. Investors seeking more comprehensive analysis can find 13 additional InvestingPro Tips for AstraZeneca, offering deeper insights into the company's financial health and market position.
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