FDA Approves AbbVie (ABBV) VENCLEXTA and Acalabrutinib Combination for First-Line CLL

AbbVie Inc. (NYSE:ABBV) is one of the best value stocks to buy now. On February 20, the US FDA approved the combination of VENCLEXTA (venetoclax) and acalabrutinib as a first-line treatment for adults with chronic lymphocytic leukemia/CLL. This establishes the first and only all-oral, fixed-duration regimen for previously untreated patients, providing a new alternative to traditional chemoimmunotherapy.

By combining two classes of oral medications, the treatment offers patients the potential for periods of time off therapy, marking a significant advancement in the long-term management of this common adult leukemia. The approval is based on results from the Phase 3 AMPLIFY trial, which demonstrated that the VENCLEXTA and acalabrutinib combination significantly reduced the risk of disease progression or death by 35% compared to standard chemoimmunotherapy.

The safety profile remained consistent with the known effects of each drug, with the most common adverse reactions including neutropenia, headache, and diarrhea. VENCLEXTA, developed by AbbVie Inc. (NYSE:ABBV) and Roche, works by inhibiting the BCL-2 protein to help restore the natural self-destruction process of cancer cells. While this new combination expands flexibility for providers and patients, it does carry risks of serious side effects such as tumor lysis syndrome, which requires preventative hydration and close monitoring by healthcare professionals.

AbbVie Inc. (NYSE:ABBV) is a research-based biopharmaceutical company that researches & develops, manufactures, commercializes, and sells medicines and therapies worldwide.

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