Posted from: Friday, December 01, 2017 - 02:08 PM - Present

Calquence Approved for Mantle Cell Lymphoma

October 31, 2017 – The U.S. FDA has approved Calquence® (acalabrutinib), manufactured by AstraZeneca, to treat mantle cell lymphoma (MCL) in adults who have previously received at least one other therapy for MCL. A bruton tyrosine kinase (BTK) inhibitor, Calquence works by blocking an enzyme that contributes to the growth and spread of cancer.

MCL is an aggressive form of non-Hodgkin’s lymphoma (NHL) that is diagnosed in an estimated 3,300 Americans annually, accounting for three to ten percent of NHL diagnoses in the United States. When found, the cancer has typically metastasized and affected the lymph nodes, bone marrow, and other organs. Often, patients treated for MCL who show improvement experience a relapse of the disease 

In a clinical study, 40% of patients treated with Calquence showed a complete response, while an additional 40% of patients experienced a partial response. Results were achieved within an average timespan of two months. In some cases, the duration of response had continued 20 months after treatment. It is not yet known what the median duration of response may be for Calquence.

Recommended dosing for Calquence is one 100mg oral capsule every 12 hours. Potential side effects include anemia, platelets (thrombocytopenia) and neutrophils (neutropenia) in the blood, irregular heartbeat (atrial fibrillation), hemorrhage, infection, and secondary cancers.

Calquence received approval using the Accelerated Approval pathway, and requires further study to verify its clinical benefits. AstraZeneca is currently conducting a trial to fulfill this requirement. Calquence is also being studied as a possible treatment for other cancers, and as a first-line therapy for MCL when used in conjunction with Treanda® (bendamustine), manufactured by Cephalon, and Rituxan® (rituximab), manufactured by Genentech.

One other BTK inhibitor—Imbruvica® (ibrutinib), manufactured by Janssen and Pharmacyclics—is already on the market, and is approved to treat other cancers in addition to MCL. Velcade® (bortezomib), manufactured by Takeda, and Revlimid® (lenalidomide), manufactured by Celgene, also hold FDA approval to treat MCL.

AstraZeneca has already launched Calquence at an estimated annual cost of $171,000.

 

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Last Updated Tuesday, July 17, 2018 - 01:03 PM.