20th Feb 2026 10:45
(Alliance News) - AbbVie Inc and AstraZeneca PLC on Friday hailed a regulatory win for their joint cancer treatment programme.
Chicago, Illinois-based AbbVie said the US Food & Drug Administration had approved a supplemental new drug application for its Venclexta or venetoclax, combined with AstraZeneca's Calquence, also known as acalabrutinib.
The oral drug regimen aims to treat adults with chronic lymphocytic leukaemia, or CLL, and small lymphocytic lymphoma. It adds the US to existing jurisdictions where it is already cleared, including the EU, UK and Canada. The latest decision greenlights the combination as a fixed-duration, first-line treatment, based on positive results from a third-phase trial sponsored by AstraZeneca.
The Cambridge, England-based pharmaceutical firm noted that patients dosed with the drug combination "were progression free at three years, versus 67% of patients treated with standard-of-care chemotherapy". The firm noted that median progression-free survival was not reached versus 47.6 months for chemoimmunotherapy. Calquence and venetoclax reduced the risk of disease progression or death by 35% compared to standard-of-care, AstraZeneca added.
Dave Fredrickson, the firm's executive vice president of Oncology Haematology commented: "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."
Svetlana Kobina, 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."
AbbVie shares edged up 0.1% to USD224.61 pre-market on Friday morning in New York. AstraZeneca traded 0.4% higher at 15,344.40 pence in London.
By Holly Munks, Alliance News reporter
Comments and questions to [email protected]
Copyright 2026 Alliance News Ltd. All Rights Reserved.
Related Shares:
Astrazeneca