FDA Approves Calquence Plus Venetoclax as First All-Oral Fixed-Duration CLL Regimen
US FDA approved Calquence (acalabrutinib) plus venetoclax as the first all-oral, fixed-duration regimen for adults with chronic lymphocytic leukaemia and small lymphocytic lymphoma. Approval based on AMPLIFY phase III trial showing 77% progression-free at three years vs 67% with chemoimmunotherapy. Regimen already cleared in EU, UK, and Canada.
The US Food and Drug Administration (FDA) has approved AstraZeneca's Calquence (acalabrutinib) in combination with AbbVie's Venclexta (venetoclax) as the first all-oral, fixed-duration regimen for adult patients with chronic lymphocytic leukaemia (CLL) and small lymphocytic lymphoma (SLL). The approval, based on positive results from the AMPLIFY phase III trial, adds the US to jurisdictions where the combination is already cleared, including the EU, UK and Canada.
The AMPLIFY trial results, presented at the American Society of Hematology 2024 Annual Meeting and published in The New England Journal of Medicine, showed that 77% of patients treated with Calquence plus venetoclax were progression-free at three years, versus 67% of patients treated with standard-of-care chemotherapy (investigator's choice of fludarabine-cyclophosphamide-rituximab or bendamustine-rituximab). Median progression-free survival was not reached versus 47.6 months for chemoimmunotherapy. The combination reduced the risk of disease progression or death by 35% compared with chemoimmunotherapy (hazard ratio 0.65; 95% confidence interval 0.49-0.87; p=0.0038). The safety and tolerability of Calquence was consistent with its known safety profile, and no new safety signals were identified.
The regimen is approved as a fixed-duration, first-line treatment. AstraZeneca's executive vice president of oncology haematology said: "This Calquence combination has the potential to meaningfully change 1st-line chronic lymphocytic leukaemia treatment decisions and underscores our commitment to improving on the current standard of care for people living with blood cancers." AbbVie's vice president of global medical affairs, oncology, said: "This FDA approval marks a significant milestone for AbbVie and, more importantly, for people living with CLL. As the first and only all-oral, fixed-duration combination regimen for previously untreated patients, the Venclexta plus acalabrutinib approval expands choice and flexibility for patients and providers navigating complex treatment decisions in CLL."
CLL is the most common type of leukaemia in adults. An estimated 18,500 people were treated for CLL in the first-line setting in the US in 2024. The approval was granted via a supplemental new drug application for Venclexta. Regulatory applications for the regimen based on the AMPLIFY results are currently under review in additional countries.