AbbVie received FDA approval on February 19, 2026 for its all‑oral, fixed‑duration combination of Venclexta (venetoclax) and acalabrutinib for patients with previously untreated chronic lymphocytic leukemia (CLL). The approval follows the Phase 3 AMPLIFY trial, which demonstrated a 35 % reduction in the risk of disease progression or death compared with standard chemoimmunotherapy and a median progression‑free survival that was not reached versus 47.6 months for chemoimmunotherapy.
The AMPLIFY study enrolled 867 fit patients without a 17p deletion or TP53 mutation and administered the combination for 14 cycles (approximately 14 months). The trial’s design and patient population underscore the therapy’s suitability for a broad segment of newly diagnosed CLL patients, and the robust efficacy data support the FDA’s decision.
Venclexta is a BCL‑2 inhibitor developed by AbbVie and Genentech (a Roche Group company) and is jointly commercialized in the U.S., while acalabrutinib is a Bruton tyrosine kinase (BTK) inhibitor developed by AstraZeneca. The combination targets two key survival pathways in CLL cells, providing a synergistic therapeutic effect.
This approval marks the first and only all‑oral, fixed‑duration regimen for newly diagnosed CLL, offering patients a defined treatment course and the possibility of “time off treatment.” The new therapy expands AbbVie’s oncology portfolio beyond its flagship Humira, diversifying revenue streams and strengthening its competitive position against Roche, Janssen, and Bristol‑Myers Squibb.
Svetlana Kobina, vice president of global medical affairs, oncology at AbbVie, 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.”
The approval is expected to open a new revenue stream in a market increasingly favoring oral targeted therapies. By providing a time‑limited, patient‑friendly option, AbbVie positions itself to capture a growing share of the CLL treatment landscape and to reinforce its strategy of building a diversified, high‑margin oncology portfolio.
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