AbbVie Receives FDA Approval for Navitoclax Plus Ruxolitinib in Myelofibrosis

AbbVie today announced that the FDA has approved navitoclax in combination with ruxolitinib for the treatment of adults with intermediate or high-risk myelofibrosis who are JAK inhibitor-naive. The approval was based on results from the Phase 3 TRANSFORM-1 trial, which demonstrated superior spleen volume reduction and symptom improvement with the combination compared to ruxolitinib alone. The ≥35% spleen volume reduction rate was 63.2% for navitoclax plus ruxolitinib versus 31.5% for ruxolitinib alone. This approval provides patients with myelofibrosis a new combination treatment option with superior efficacy compared to ruxolitinib monotherapy.