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The FDA has granted accelerated approval to acalabrutinib, a kinase inhibitor indicated for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy.

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Acalabrutinib is approved under the FDA's accelerated approval pathway, based on overall response rate, which allows for earlier approval of medicines that treat serious conditions and that fill an unmet medical need based on a surrogate endpoint. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.


"The acalabrutinib approval represents an important development for patients currently battling mantle cell lymphoma, an aggressive type of blood cancer that is typically diagnosed at an advanced stage and associated with a high relapse rate," said Michael L. Wang, MD, Professor, Department of Lymphoma/Myeloma, The University of Texas MD Anderson Cancer Center, Houston, and Principal Investigator of the ACE-LY-004 MCL clinical trial. "In addition to the overall response rate, the high complete response rate of 40 percent seen in this trial illustrates the potential of acalabrutinib to help patients."


As assessed by Independent Review Committee, the key efficacy results from the ACE-LY-004 trial in 124 adult patients with relapsed or refractory MCL included overall response rate (80%), complete response (40%), and partial response (40%).


In the trial, the most common adverse reactions (>=20%) of any grade were anemia (46%), thrombocytopenia (44%), headache (39%), neutropenia (36%), diarrhea (31%), fatigue (28%), myalgia (21%), and bruising (21%). Hematological events were based on laboratory measurements and adverse reactions.


Dosage reductions or discontinuations due to any adverse reaction were reported in 1.6 percent and 6.5 percent of patients, respectively. Increases in creatinine 1.5-3 times the upper limit of normal occurred in 4.8 percent of patients. These data demonstrate the potential impact that acalabrutinib could have on the management of previously treated MCL.


Meghan Gutierrez, Chief Executive Officer, Lymphoma Research Foundation, noted: "Relapse is common in mantle cell lymphoma patients and represents disease progression. When patients learn there is a new treatment option available for their disease, it brings great hope and an opportunity to participate in shared decision-making with their health care team."