AbbVie Seeks FDA Approval for CLL Treatment Combination Regimen

AbbVie submitted a Supplemental New Drug Application for a new CLL treatment regimen, aligning with its oncology pipeline expansion strategy. Positive Phase 3 trial results support this move, potentially enhancing revenue and earnings potential. The share price rose 3.4% over the past month, bolstered by the submission news and broader market optimism. Analysts target a price of $210.08, with the current share price at $188.52, reflecting a potential 11% upside.

AbbVie Inc. has submitted a Supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for the fixed-duration, all-oral combination regimen of VENCLEXTA® (venetoclax) and acalabrutinib in previously untreated patients with chronic lymphocytic leukemia (CLL). This move aligns with the company's oncology pipeline expansion strategy and is supported by positive results from a Phase 3 clinical trial [1].

The combination regimen, which includes VENCLEXTA and acalabrutinib, has shown statistically significant improvement in progression-free survival (PFS) compared to standard chemoimmunotherapy in previously untreated patients with CLL. This regimen offers the potential for time-limited treatment, providing patients with an opportunity to take time off treatment if approved, which could be a significant advancement in frontline CLL care [1].

AbbVie's vice president of global medical affairs and oncology, Svetlana Kobina, noted that this submission marks a milestone for CLL treatment. She emphasized that the new fixed-treatment duration approach could offer patients the opportunity for time off treatment, potentially transforming the way CLL is managed [1].

The submission is based on the Phase 3 AMPLIFY trial, which demonstrated a 35% reduction in the risk of disease progression or death compared to chemoimmunotherapy. The safety profile of the combination regimen was consistent with the known safety profiles of each individual therapy alone [1].

AbbVie's stock price has seen a 3.4% increase over the past month, driven by the submission news and broader market optimism. Analysts are targeting a price of $210.08, with the current share price at $188.52, reflecting a potential 11% upside [2].

References:
[1] https://www.chicagobusiness.com/health-pulse/abbvie-submits-new-drug-combo-treat-leukemia
[2] https://www.prnewswire.com/news-releases/abbvie-submits-for-us-fda-approval-of-combination-treatment-of-venclexta-venetoclax-and-acalabrutinib-for-previously-untreated-patients-with-chronic-lymphocytic-leukemia-cll-302515390.html