HQ Team
October 3, 2024: British-Swedish AstraZeneca’s drug for treatment of a form of blood cancer has been granted a Priority Review in the US by the drug regulator.
Calquence, the company’s brand name for acalabrutinib, has been granted the review for treating adult patients with previously untreated mantle cell lymphoma, according to a statement.
The Food and Drug Administration grants the review for medicines that, if approved, would offer significant improvements over available options by demonstrating safety or efficacy improvements, preventing serious conditions or enhancing patient compliance.
The Prescription Drug User Fee Act date, the FDA action date for their regulatory decision, is anticipated during the first quarter of 2025.
Mantle zone
Mantle cell lymphoma is a rare and typically aggressive form of non-Hodgkin lymphoma which is a form of cancer that affects the lymphatic system.
Lymphomas are cancers that involve white blood cells and can be divided depending on the type of cell involved, either B-lymphocytes or T-lymphocytes.
Mantle cell lymphoma is a B-cell lymphoma that develops from malignant B-lymphocytes within a region of the lymph node known as the mantle zone. It affects mostly men who are usually 60 to 70 years old.
The disease is often diagnosed at advanced stages and remains largely incurable. It is estimated that more than 27,500 people are living with the disease worldwide.
Easy bruising
Symptoms include swollen painless lymph nodes, headache, weakness, decreased appetite, and indigestion.
Other non-specific symptoms may include fever, weight loss, sweating at night, fatigue, reduced energy, easy bruising or bleeding. Several treatment options are available.
Data from the drug’s end-stage trial showed progress, said Susan Galbraith, Executive Vice President of Oncology R&D at AstraZeneca.
Calquence when combined with chemoimmunotherapy significantly delayed disease progression and “showed a trend of improved survival in patients with this currently incurable blood cancer,” she said.
The drug combined with bendamustine and rituximab reduced the risk of disease progression or death by 27% compared to standard-of-care chemoimmunotherapy.
The addition of Calquence to standard-of-care treatment provided almost 1.5 years of additional median progression-free survival.
