EC’s approval comes after the Committee for Medicinal Products for Human Use’s positive opinion.
It is based on the data obtained from the ELEVATE-PLUS trials, which include three single-dose, open-label, cross-over Phase I trials conducted in 116 healthy participants.
The studies established bioequivalence between acalabrutinib 100mg tablets and acalabrutinib 100mg capsules.
Findings demonstrated that the Calquence capsule and tablet formulations are bioequivalent in the trials.
AstraZeneca Oncology Business Unit executive vice-president Dave Fredrickson said: “The Calquence tablet formulation underscores our commitment to understanding the needs of the chronic lymphocytic leukaemia community and providing patient-oriented treatment solutions.
“Today’s approval offers physicians and patients in the EU more flexibility to determine the right treatment plan and enables more patients to potentially benefit from this medicine.”
In a separate development, AstraZeneca has received EC approval for its Imfinzi (durvalumab) and Imjudo (tremelimumab) immunotherapy combinations to treat advanced liver and lung cancers.
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