CALQUENCE (acalabrutinib), was granted accelerated approval today by the FDA.
The specialty pharmacy will provide access to this FDA-approved, second-generation treatment for mantle cell lymphoma |
| [31-October-2017] |
| PHOENIX, Oct. 31, 2017 /PRNewswire/ -- Avella announced that it has been selected by AstraZeneca to distribute CALQUENCE® (acalabrutinib), a Bruton tyrosine kinase (BTK) inhibitor indicated for patients with mantle cell lymphoma (MCL) who have received at least one prior therapy. CALQUENCE® (acalabrutinib), was granted accelerated approval today by the US Food and Drug Administration (FDA). BTK is an enzyme that plays a critical role in the function of B cells within the immune system. B cells are a type of white blood cell that produces antibodies used to attack invading bacteria, viruses, and toxins in the body. As such, BTK is also an important regulator of cell growth and survival in B cell cancers like MCL. CALQUENCE® (acalabrutinib), received orphan drug designation by the FDA in 2015 as well as breakthrough therapy designation earlier this year. The FDA also granted a Priority Review for acalabrutinib, which is an expedited review process applied only to medicines that may offer a significant improvement in the safety or efficacy of treatment, diagnosis or prevention of serious conditions. The drug was developed by AstraZeneca’s hematology research and development center of excellence, Acerta Pharma. “CALQUENCE is filling a distinct need for new and better treatments for mantle cell lymphoma,” said Leslie Yendro, RN, Vice President of Business Development for Avella Specialty Pharmacy. “By combining access to this cutting-edge therapy with our proven oncology expertise and patient support model, Avella can serve as a valuable resource for these patients and their physicians.” MCL is one of approximately 70 different subtypes of non-Hodgkin lymphoma, a life-threatening cancer arising from B cells. MCL is generally considered an aggressive type of B-cell non-Hodgkin lymphoma and has historically been difficult to treat, with many patients experiencing relapses even after therapy. In the US, MCL patients represent only about 6 percent (about 4,200 cases) of all new cases of non-Hodgkin lymphoma and the condition is diagnosed most commonly in older adults. About Avella Specialty Pharmacy Todd Speranzo
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