AbbVie Seeks FDA Nod for Oral CLL Therapy with Venclexta

AbbVie announced that it has submitted a supplemental New Drug Application to the U.S. FDA for a new fixed-duration, oral CLL therapy with Venclexta and acalabrutinib for the treatment of previously untreated chronic lymphocytic leukemia.

With this submission AbbVie hopes to offer this patient population an entirely new treatment paradigm that offers a time limited oral regimen compared to traditional chemoimmunotherapy options.

The sNDA submission is supported by strong data that stemmed from the Phase 3 AMPLIFY trial and this was a pivotal trial that demonstrated the improved progression-free survival with the Venclexta-acalabrutinib combination versus that of the standard chemoimmunotherapy regimens.

Also Read: Role of Optical Imaging in Early Cancer Detection and Treatment

 The strong results from the study indicate that the Venclexta-acalabrutinib treatment will potentially offer improved convenience with a single predefined timeframe for treatment and reduce the burden of long-term therapy on patients without compromising efficacy. We hope patients will have the opportunity to complete therapy and return to normalcy, and improvements to their quality of life.

Svetlana Kobina, Vice President of Global Medical Affairs, Oncology at AbbVie, emphasized the significance of this development, stating, “This submission could mark a shift in frontline CLL treatment, offering patients a time-limited oral option.” The all-oral regimen is particularly noteworthy, as it eliminates the need for intravenous treatments, potentially improving accessibility and patient compliance.

AbbVie’s pursuit of FDA approval for this combination therapy underscores its commitment to advancing oncology care, particularly for CLL, a common form of leukemia in adults. If approved, the Venclexta-acalabrutinib combination could redefine standard care for untreated CLL patients, offering a more streamlined and patient-friendly treatment pathway.

The oncology community and patients alike await the FDA’s review, which could herald a new era in CLL management with a focus on efficacy, convenience, and quality of life.