FDA: Calquence for the treatment of adult patients with chronic lymphocytic leukemia or small lymphocytic lymphoma
The FDA ( U.S. Food and Drug Administration ) has approved Calquence ( Acalabrutinib ) for the treatment of adult patients with chronic lymphocytic leukemia ( CLL ) or small lymphocytic lymphoma ( SLL ).
Acalabrutinib is a Bruton tyrosine kinase ( BTK ) inhibitor; it binds covalently to BTK, inhibiting its activity.
In B-cells, BTK signaling results in activation of pathways necessary for B-cell proliferation, trafficking, chemotaxis and adhesion.
Data from two separate phase III trials, ASCEND and ELEVATE-TN, were used as the basis for the Breakthrough Therapy Designation as well as the approval.
The ELEVATE-TN trial was halted in June after Acalabrutinib hit its endpoints following an interim analysis.
Acalabrutinib combined with Obinutuzumab ( Gazyva ) and as monotherapy reduced the risk of disease progression or death by 90% and 80%, respectively in ELEVATE-TN.
Acalabrutinib met primary endpoints in patients with previously-untreated CLL, which is the most common type of leukemia in adults.
In May, AstraZeneca halted the ASCEND trial early after the medication hits endpoint at an interim analysis.
Similar to the ELEVATE-TN study, ASCEND data showed that Acalabrutinib hit the mark in progression-free survival in previously-treated CLL patients.
The ASCEND trial marked the first time a BTK inhibitor showed a benefit in CLL as a monotherapy.
Together, the trials showed that Calquence in combination with Obinutuzumab or as a monotherapy significantly reduced the relative risk of disease progression or death versus the comparator arms in both 1st-line and relapsed or refractory CLL.
Calquence is also approved for the treatment of adults with relapsed or refractory mantle cell lymphoma ( MCL ). ( Xagena )
Source: AstraZeneca, 2019