FDA OKs GSK’s Blood Cancer Drug

FDA has approved a GlaxoSmithKline NDA for Ojjaara (momelotinib) for treating intermediate or high-risk myelofibrosis, including primary myelofibrosis or secondary myelofibrosis (post-polycythaemia vera and post-essential thrombocythaemia), in adults with anemia. Ojjaara is described as a once-a-day, oral JAK1/JAK2 and activin A receptor type 1 (ACVR1) inhibitor.

Approval is based on data from the pivotal MOMENTUM study that met all its primary and key secondary endpoints, “demonstrating statistically significant response with respect to constitutional symptoms, splenic response and transfusion independence, in patients treated with momelotinib versus danazol, the company says. Data from SIMPLIFY-1 also supported approval, it says.

Myelofibrosis is a rare blood cancer that results from dysregulated JAK-signal transducer and activator of transcription protein signaling and is characterized by constitutional symptoms, splenomegaly, and progressive anemia, according to GSK.