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The Food and Drug Administration has granted traditional approval to Calquence with bendamustine and Rituxan for some patients with MCL.
The Food and Drug Administration (FDA) has granted traditional approval to Calquence (acalabrutinib) with bendamustine and Rituxan (rituximab) for adults with previously untreated mantle cell lymphoma (MCL) who are ineligible for autologous hematopoietic stem cell transplantation (HSCT), the agency has announced.
The agency also announced that it has granted traditional approval to Calquence as a single agent treatment for adults with previously treated MCL. The drug received an accelerated approval for this indication in 2017, the agency noted.
Progression-free survival: the time a patient lives without their disease spreading or worsening.
Pyrexia: fever
Febrile neutropenia: fever in a patient with neutropenia, or a low count of neutrophils, a type of white blood cell.
Atrial fibrillation: irregular heartbeat.
Calquence’s efficacy was determined in the ECHO trial which evaluated 598 patients with MCL who were at least 65 years old and not intended to receive HSCT. Patients received Calquence plus bendamustine and Rituxan or placebo plus bendamustine and Rituxan.
At a median follow-up of 49.8 months, the median progression-free survival was 66.4 months in the Calquence arm and 49.6 in the placebo arm.
Serious adverse reactions occurred in 69% of patients on the Calquence arm, with fatal adverse reactions occurring in 12%. Serious adverse reactions reported in at least 2% of patients included pneumonia, COVID-19, pyrexia, second primary malignancy, rash, febrile neutropenia, atrial fibrillation, sepsis and anemia.
The recommended dose of Calquence is 100 milligrams orally approximately every 12 hours until disease progression or unacceptable toxicity.
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