AbbVie has submitted a supplemental New Drug Application to the U.S. Food and Drug Administration for the combination of VENCLEXTA (venetoclax) and acalabrutinib as an all-oral, fixed-duration treatment regimen for patients with previously untreated chronic lymphocytic leukemia (CLL). The submission is supported by data from the Phase 3 AMPLIFY trial.
The AMPLIFY trial, sponsored by AstraZeneca, compared VENCLEXTA plus acalabrutinib—with or without obinutuzumab—against standard chemoimmunotherapy in CLL patients without certain genetic mutations. According to results presented at the 2024 American Society of Hematology Annual Meeting, the combination reduced the risk of disease progression or death by 35% compared to chemoimmunotherapy. The safety profile observed was consistent with what is known for each therapy alone, with neutropenia being the most frequent Grade 3 or higher adverse event. Low rates of tumor lysis syndrome were also noted in patients on this regimen.
Svetlana Kobina, vice president of global medical affairs, oncology at AbbVie, said: "This FDA submission marks a milestone for CLL treatment with the potential approval for the first oral combination regimen of VENCLEXTA and acalabrutinib for previously untreated patients with chronic blood cancer. This new fixed-treatment duration approach could allow patients the opportunity for time off treatment, if approved, and be potentially practice-changing in frontline CLL care."
VENCLEXTA is jointly developed by AbbVie and Roche and is approved in more than 80 countries worldwide. In addition to its use in CLL or small lymphocytic lymphoma (SLL), it is also used in combination therapies for adults newly diagnosed with acute myeloid leukemia who are not eligible for standard chemotherapy.
Patients taking VENCLEXTA may experience serious side effects such as tumor lysis syndrome (TLS), low white blood cell counts (neutropenia), and infections including pneumonia or sepsis. Healthcare providers monitor these risks closely through blood tests and may adjust dosing as needed.
AbbVie states that it aims to develop innovative medicines across several therapeutic areas including oncology, immunology, neuroscience, eye care, and aesthetics. The company reports having more than 20 investigational medicines under evaluation in multiple clinical trials targeting various cancers globally.
More information about the AMPLIFY study can be found at https://clinicaltrials.gov/study/NCT03836261 and details from its interim analysis are available at https://ashpublications.org/blood/article/144/Supplement%201/1009/530876/Fixed-Duration-Acalabrutinib-Plus-Venetoclax-with.
"This FDA submission marks a milestone for CLL treatment with the potential approval for the first oral combination regimen of VENCLEXTA and acalabrutinib for previously untreated patients with chronic blood cancer. This new fixed-treatment duration approach could allow patients the opportunity for time off treatment, if approved, and be potentially practice-changing in frontline CLL care," said Svetlana Kobina, vice president, global medical affairs, oncology, AbbVie.
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