What's Happening?
The U.S. Food and Drug Administration (FDA) has approved the first all-oral, fixed-duration regimen for patients with newly-diagnosed chronic lymphocytic leukemia (CLL). This regimen combines AstraZeneca's Calquence (acalabrutinib) and AbbVie/Roche's
Venclexta (venetoclax). The approval is based on the results of the AMPLIFY trial, which demonstrated the regimen's effectiveness in adult CLL patients without del(17p) or TP53 mutations. The trial results were initially presented at the ASH congress in 2024. The new regimen allows patients to avoid traditional chemoimmunotherapy, which often involves a combination of fludarabine, cyclophosphamide, and rituximab (FCR) or bendamustine plus rituximab. Unlike continuous regimens, the Calquence/Venclexta combination is administered for a fixed 14-month period, potentially reducing long-term side effects and treatment resistance.
Why It's Important?
This approval marks a significant advancement in the treatment of CLL, providing patients with a more convenient and potentially less burdensome option compared to traditional chemoimmunotherapy. The fixed-duration regimen allows for treatment breaks, which can reduce the risk of long-term side effects and improve patients' quality of life. The approval also reflects a shift in the competitive landscape of CLL treatments, with new therapies like BeOne's Brukinsa and Eli Lilly's Jaypirca emerging as strong competitors. The Calquence/Venclexta regimen's ability to reduce the risk of disease progression or death by 35% compared to chemoimmunotherapy highlights its potential to become a preferred treatment option for CLL patients.
What's Next?
The approval of the Calquence/Venclexta regimen is expected to influence treatment strategies for CLL, offering healthcare providers greater flexibility in tailoring treatment plans to individual patient needs. As the regimen gains traction, it may prompt further research and development of similar all-oral treatment options. Additionally, the success of this regimen could encourage pharmaceutical companies to explore new combinations and fixed-duration therapies for other types of cancer. The ongoing competition among pharmaceutical companies in the CLL treatment market is likely to drive innovation and improve patient outcomes.
