According to a story from World Pharma News, the pharmaceutical company AstraZeneca has recently announced that the company’s supplemental New Drug Application for acalabrutinib (marketed as Calquence) was recently accepted by the US Food and Drug Administration (FDA). It has also been granted Priority Review for the treatment of mantle cell lymphoma in adults who haven’t attempted any prior therapy.
The announcement follows results from the phase III ECHO clinical trial, in which Calquence combined with bendamustine and rituximab brought down the risk of death or disease progression by 27% when compared to chemoimmunotherapy standard-of-care. This translated into 1.5 years more median progression-free survival. Overall survival (OS) also was favorable for the combination, though the OS survival in the trial has not yet completed.
About Priority Review
The FDA’s Priority Review is granted to therapies that, with approval, would allow for meaningful improvements over current options in terms of efficacy or safety, or that provide an option in a disease where none is currently approved. This status does not impact clinical trial duration or otherwise alter the scientific and medical standards necessary for approval. Instead, it shortens the approval process with the agency from a standard duration of 10 months to just 6 months. An applicant may specifically request priority review during the submission process.
About Mantle Cell Lymphoma
Mantle cell lymphoma is a rare type of non-Hodgkin’s lymphoma. There are only about 15,000 patients in the US. This blood cancer affects B-cells, a type of white blood cell. The risk factors for mantle cell lymphoma are not particularly well known; however, acquired genetic mutations in the affected cells are what eventually causes them to become malignant. Most patients are diagnosed in their 60s. In many cases, the disease is not diagnosed until it has reached an advanced stage. Symptoms include fever, night sweats, enlarged spleen and lymph nodes, and weight loss. Treatment options include immunotherapy, chemotherapy, and targeted therapies. Mantle cell lymphoma often relapses after treatment with chemotherapy. Prognosis is difficult to predict; the five-year survival rate is 50%, but this figure improves to 70% with limited-stage disease. To learn more about mantle cell lymphoma, click here.
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Last modified: November 20, 2024
