FDA approves Calquence to treat chronic lymphocytic leukaemia or small lymphocytic lymphoma.- AstraZeneca.
AstraZeneca announced that the FDA has approved Calquence (acalabrutinib) for adult patients with chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL). The US approval was granted under the FDA�s Real-Time Oncology Review and newly established Project Orbis programmes.
The approval is based on positive results from the interim analyses of two Phase III clinical trials, ELEVATE-TN in patients with previously untreated CLL and ASCEND in patients with relapsed or refractory CLL. 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. Across both trials, the safety and tolerability of Calquence were consistent with its established profile.
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