Dr. Mesa on the FDA Approval of Fedratinib in Myelofibrosis

Ruben A. Mesa, MD, director, The Mays Cancer Center, the newly named center of UT Health San Antonio MD Anderson Cancer Center, discusses the FDA approval of fedratinib (Inrebic) in myelofibrosis.

On August 16 2019, the FDA approved fedratinib for the treatment of adult patients with intermediate-2 or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis.

Findings from the phase III JAKARTA2 and phase II JAKARTA-2 trials served as the basis for the approval. These trials evaluated fedratinib in patients with primary or secondary myelofibrosis, and in those patients who were previously exposed to ruxolitinib (Jakafi), respectively. Results of both studies demonstrated a significant reduction in splenomegaly and symptom burden in patients with myelofibrosis.

There are significant unmet needs for patients with myelofibrosis despite the availability of ruxolitinib, says Mesa. The approval of fedratinib enables greater treatment flexibility and may open additional avenues of investigation into other novel therapies and combinations.