FDA grants full approval for AstraZeneca's Calquence
The US Food and Drug Administration has granted AstraZeneca’s (LSE: AZN) Calquence (acalabrutinib) full approval as part of a combination therapy for mantle cell lymphoma (MCL).
The nod covers the first-line treatment of adults who are ineligible for autologous hematopoietic stem cell transplantation. Calquence also received full approval as a monotherapy for previously treated MCL, converting its 2017 accelerated approval into a traditional one.
The decision was supported by data from the Phase III ECHO trial, which showed a 27% lower risk of disease progression or death, and a median progression-free survival (PFS) of 66.4 months, compared to 49.6 months in the comparator group.
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