AstraZeneca Earns Breakthrough Designation for Leukemia

AstraZeneca received breakthrough therapy designation from the FDA for Calquence (acalabrutinib) for treatment of chronic lymphocytic leukemia.

The agency granted the designation based on results from two phase 3 trials, which showed that the drug alone or in combination increased the time patients lived without disease progression.

Calquence received accelerated approval from the FDA in 2017 for treating adults with mantle cell lymphoma who have received at least one prior therapy.