The European Commission (EC) has granted approval for AstraZeneca’s tablet formulation of Calquence (acalabrutinib) to treat chronic lymphocytic leukaemia (CLL) in adult patients.
The selective Bruton’s tyrosine kinase (BTK) inhibitor Calquence binds covalently to BTK, and then inhibit its activity.
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.
They assessed the proton pump inhibitors (PPI) effect of acalabrutinib tablets given in the presence against the absence of PPI rabeprazole.
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 the US, Calquence received approval as a capsule and tablet formulation to treat CLL, small lymphocytic lymphoma (SLL) and relapsed or refractory mantle cell lymphoma (MCL) patients.
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.
The combination of Imfinzi with Imjudo received approval for the first-line treatment of advanced or unresectable hepatocellular carcinoma (HCC) in adult patients.
Imfinzi along with Imjudo and platinum-based chemotherapy, received approval to treat metastatic (Stage IV) non-small cell lung cancer (NSCLC) in these patients.
The two regulatory approvals are based on the data obtained from the Phase III HIMALAYA and POSEIDON trials.