AstraZeneca's Calquence Regimens Recommended for EU Approval in First-Line CLL

AstraZeneca's Calquence Regimens Recommended for EU Approval in First-Line CLL

A fixed-duration regimen of AstraZeneca's Calquence (acalabrutinib) in combination with venetoclax, with or without obinutuzumab, has received a recommendation for approval within the European Union for treating adult patients with previously untreated chronic lymphocytic leukemia (CLL).

The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) based its positive opinion on the results from the Phase III AMPLIFY trial. The trial demonstrated that Calquence combinations showed a statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared to standard chemoimmunotherapy.

Treatment with Calquence plus venetoclax reduced the risk of disease progression or death by 35% compared to standard care. With the addition of obinutuzumab, the risk reduction reached 58%. After three years, 77% of patients in the Calquence plus venetoclax arm and 83% in the Calquence plus venetoclax with obinutuzumab arm remained progression-free, versus 67% of those who received chemoimmunotherapy.

Physicians have highlighted that fixed-duration Calquence regimens allow for treatment breaks, which could reduce the risk of long-term adverse events and drug resistance. Chronic lymphocytic leukemia is the most common type of leukemia affecting adults in Europe.

AstraZeneca stated that this recommendation could position Calquence plus venetoclax as the only approved, all-oral, second-generation BTK inhibitor option in Europe for patients with previously untreated CLL. The pharmaceutical company anticipates regulatory approvals in several countries based on these results.