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A second JAK inhibitor for myelofibrosis that works after ruxolitinib fails; it carries a boxed warning for a rare brain toxicity (Wernicke encephalopathy) so thiamine is checked.
Fedratinib is a selective JAK2 inhibitor, with additional FLT3 and BRD4 activity, that reduces JAK-STAT signalling to shrink the spleen and ease symptoms in myelofibrosis. In JAKARTA (first line) and JAKARTA-2 (after ruxolitinib) about 35 to 45% of patients achieved a spleen response, giving it evidence in ruxolitinib failure. Development was halted in 2013 after cases of encephalopathy and resumed after review; it was approved in the US in 2019 for intermediate-2 or high-risk primary or secondary myelofibrosis and in the EU in 2021, with a boxed warning for Wernicke encephalopathy, so thiamine is checked before and during treatment. Anaemia and thrombocytopenia occur as with other JAK inhibitors. For a newcomer: a myelofibrosis pill that works after ruxolitinib, with a rare brain toxicity that vitamin monitoring prevents.
Selective JAK2 inhibitor (also FLT3, BRD4) reducing JAK-STAT signalling and splenomegaly. Connects to JAK2, FLT3 and BRD4.
1.Fedratinib slips into a pocket on JAK2.
Oral, self-administered, so it is a Part D drug: covered through a stand-alone Part D plan or Medicare Advantage drug benefit, usually on the specialty tier with 25 to 33% coinsurance until the annual cap ($2,000 in 2025, $2,100 in 2026).
Covered for FDA-labelled and NCCN-listed uses, but almost always behind prior authorisation confirming diagnosis, biomarker and line of therapy; dispensed through a specialty pharmacy.
Part D out-of-pocket capped at $2,000 (2025) / $2,100 (2026). Medicare patients cannot use manufacturer co-pay cards; charity funds (PAN, HealthWell, CancerCare) and the Extra Help subsidy are the routes.
Sources: Medicare.gov: Drug coverage (Part D) · Medicare.gov: Costs for Medicare drug coverage (annual out-of-pocket cap). Not medical or financial advice; verify with your plan.
Sources: NICE TA756 · SMC advice: fedratinib. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
| Region | Year | Indication |
|---|---|---|
| US | 2019 | Intermediate-2/high-risk primary or secondary myelofibrosis |
| EU | 2021 | Myelofibrosis, JAK-inhibitor-naive or after ruxolitinib |
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Query for this drug: (TITLE:"Fedratinib" OR ABSTRACT:"Fedratinib" OR TITLE:"Inrebic" OR ABSTRACT:"Inrebic") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Fedratinib, not a curated reading list.
Shares DIPSS, DIPSS-plus and MIPSS70 (myelofibrosis risk scores), COMFORT-I: ruxolitinib, the first JAK inhibitor, versus placebo for myelofibrosis, FLT3, JAK2.
Shares COMFORT-I: ruxolitinib, the first JAK inhibitor, versus placebo for myelofibrosis, Primary myelofibrosis, Myeloproliferative neoplasms (PV, ET, myelofibrosis), Small-molecule kinase inhibitors.
Shares DIPSS, DIPSS-plus and MIPSS70 (myelofibrosis risk scores), COMFORT-I: ruxolitinib, the first JAK inhibitor, versus placebo for myelofibrosis, JAK2, Primary myelofibrosis.
Shares COMFORT-I: ruxolitinib, the first JAK inhibitor, versus placebo for myelofibrosis, JAK2, Primary myelofibrosis, Myeloproliferative neoplasms (PV, ET, myelofibrosis).
Shares JAK2, Primary myelofibrosis, Myeloproliferative neoplasms (PV, ET, myelofibrosis), Small-molecule kinase inhibitors.
Shares COMFORT-I: ruxolitinib, the first JAK inhibitor, versus placebo for myelofibrosis, Myeloproliferative neoplasms (PV, ET, myelofibrosis), Small-molecule kinase inhibitors.
Shares Primary myelofibrosis, Myeloproliferative neoplasms (PV, ET, myelofibrosis), Bristol Myers Squibb.
Shares JAK2, Primary myelofibrosis, Myeloproliferative neoplasms (PV, ET, myelofibrosis).