In November 2019, the FDA accelerated the approval of a new indication for Calquence (acalabrutinib; AstraZeneca) for adults with relapsed or refractory chronic lymphocytic leukemia (CLL), as well as for those with small lymphocytic lymphoma (SLL). Calquence has been previously approved by the FDA for mantle-cell lymphoma.
This new approval was based on results from 2 clinical trials, which showed increased duration of the time without disease progression in patients who received Calquence, alone or in combination with Gazyva (obinutuzumab).
In both studies, after an average of 28.3 months, the average time without disease progression had not been reached in patients who received Calquence, as was the average time of survival, meaning that the Calquence treatment was still effective and still provided benefits after an average of more than 28 weeks.
The most common side effects of any severity in patients with CLL were anemia, neutropenia, thrombocytopenia, headache, upper respiratory tract infection, and diarrhea.
