Japanese regulator awards new oncology approvals to AstraZeneca

28 December 2022

AstraZeneca’s (LSE: AZN) Calquence (acalabrutinib) has secured a new approval in Japan, for the treatment of adults with chronic lymphocytic leukemia (CLL), in the first-line setting.

The nod for the selective Bruton’s tyrosine kinase inhibitor adds to an existing approval in CLL in the country, for relapsed or refractory CLL.

The move into the earlier treatment setting was backed by data from the Phase III ELEVATE-TN study, published in The Lancet, which showed a significant improvement in progression-free survival (PFS).

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