The approval was based on the ELEVATE-PLUS trials, which established the bioequivalence between 100mg of acalabrutinib in tablet formulation and 100mg in capsule formulation
AstraZeneca gets EC approval for the tablet formulation of Calquence for chronic lymphocytic leukaemia. (Credit: AstraZeneca)
The European Commission (EC) has approved AstraZeneca’s tablet formulation of Calquence (acalabrutinib) in the European Union (EU) for the treatment of adult patients with chronic lymphocytic leukaemia (CLL).
Calquence is a selective inhibitor of Bruton’s tyrosine kinase (BTK). It was approved by the EC in capsule formulation for the same indication in late 2020.
The EC approval comes after the positive opinion adopted by the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP). It is based on results from the ELEVATE-PLUS trials.
ELEVATE-PLUS is made up of three phase 1, open-label, single-dose, cross-over studies held in 116 healthy patients. It established the bioequivalence between 100mg of acalabrutinib in tablet formulation and 100mg in capsule formulation.
The results of the trials showed the same efficacy and safety profile for the two formulations, which can be expected when prescribed with the same dosing strength as well as schedule.
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.”
Separately, the EC has approved AstraZeneca’s Imfinzi (durvalumab) and Imjudo (tremelimumab) immunotherapy combinations for advanced liver and lung cancers.
The Imfinzi, Imjudo combination has been authorised for the first-line treatment of adults having advanced or unresectable hepatocellular carcinoma (HCC).
Imfinzi in combination with Imjudo and platinum-based chemotherapy has been approved by the EC for the treatment of metastatic non-small cell lung cancer (NSCLC) in adults.
The pharmaceutical firm said that the two approvals were backed by positive opinion from CHMP and based on the positive findings from the HIMALAYA phase 3 trial and the POSEIDON phase 3 trial.
Fredrickson said: “These approvals for Imfinzi and Imjudo bring critically needed, novel immunotherapy-based treatment regimens that will potentially deliver life-extending benefits for European patients with advanced liver and non-small cell lung cancers.”