The U.S. Food and Drug Administration (FDA) said on Tuesday it approved AstraZeneca Plc's Calquence as a treatment for a rare type of blood cancer.
MCL is one of approximately 70 different subtypes of non-Hodgkin lymphoma, a life-threatening cancer arising from B cells.
Under the Accelerated Approval pathway, the FDA may approve drugs which exhibit clinical benefit to patients with severe conditions with an unmet medical need. 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. "For patients who have not responded to treatment or have relapsed, Calquence provides a new treatment option that has shown high rates of response for some patients in initial studies".
Under the accelerated approval program, full approval for acalabrutinib is contingent on findings from confirmatory trials.
Calquence functions by blocking the BTK enzyme which is responsible for multiplication and spreading of the cancer. In non-clinical studies, Calquence inhibited BTK-mediated activation of downstream signaling proteins CD86 and CD69 and inhibited malignant B-cell proliferation and survival.
Common side effects of Calquence include headache; diarrhea; bruising; fatigue and muscle pain (myalgia); and reduced levels of red blood cells (anemia), platelets (thrombocytopenia) and neutrophils (neutropenia) in the blood.
After a median follow-up of 15.2 months, the overall response rate was 81% (95% CI, 73%-87%), with 40% (95% CI, 31%-49%) and 41% (95% CI, 32%-50%) of patients reaching a complete or partial response, respectively. Serious side effects include bleeding (hemorrhage), infections and irregular heartbeat (atrial fibrillation). The approval for the novel BTK inhibitor arrived several months ahead of expectations under the Prescription Drug User Fee Act and followed a breakthrough therapy designation from the FDA for MCL in early August.
The FDA granted the accelerated approval of Calquence to AstraZeneca Pharmaceuticals LP.
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