AbbVie Submits NDA to FDA for Navitoclax Plus Ruxolitinib in Myelofibrosis

AbbVie today announced the submission of a New Drug Application (NDA) to the FDA for navitoclax in combination with ruxolitinib for the treatment of myelofibrosis. The submission is based on positive results from the Phase 3 TRANSFORM-1 trial, which demonstrated superior spleen volume reduction with the combination compared to ruxolitinib alone. The NDA includes data from over 400 patients enrolled in the TRANSFORM-1 trial. AbbVie is working with the FDA to determine the review timeline. If approved, navitoclax plus ruxolitinib would represent a new treatment option for patients with JAK inhibitor-naive myelofibrosis.