Celgene Gets FDA Approval For Inrebic In Bone Marrow Cancer
Zacks Investment Research | Aug 18, 2019 10:24PM ET
Celgene Corporation (NASDAQ:CELG) announced that the FDA has approved Inrebic (fedratinib) for the treatment of adult patients with intermediate-2 or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis.
The drug provides a new, once-daily oral option for patients affected by rare bone marrow cancer. Between 16,000 and 18,500 patients are estimated to be living with myelofibrosis and 1.5 of every 100,000 people are expected to be diagnosed with the same annually.
The approval was based on positive results from the JAKARTA2 study. The results of the study showed that 37% of patients treated with Inrebic 400 mg experienced a 35% or more reduction in spleen volume compared to just 1% (1 of 96) of patients who received placebo.
However, Inrebic, an oral kinase inhibitor with activity against wild type and mutationally activated Janus Associated Kinase 2 (JAK2) and FMS-like tyrosine kinase 3 (FLT3), carries a boxed warning for serious and fatal encephalopathy, including Wernicke’s.
The drug was added to Celgene’s portfolio through the acquisition of Impact Biomedicines in 2018.
Competition is stiff in this market. Incyte’s (NASDAQ:INCY) Jakafi, a first-in-class JAK1/JAK2 inhibitor, is already approved for intermediate or high-risk myelofibrosis.
Nevertheless, the approval will strengthen Celgene’s oncology portfolio. Approval of new drugs and label expansion of the existing ones will drive the top line.
Celgene’s shares have soared 47.8% so far this year against the Zacks Investment Research
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