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drugsProductNot mapped hereapproved

Ropeginterferon alfa-2b

Ropeginterferon alfa-2b is a long-acting interferon for polycythaemia vera that, unlike hydroxyurea, can shrink the mutant clone over years.

PROUD-PV/CONTINUATION-PV: complete haematologic response and JAK2 allele-burden reduction superior to hydroxyurea by 3-6 years; Low-PV showed benefit in low-risk PV. First interferon approved specifically for PV (EU 2019, US 2021). Depression, autoimmunity and flu-like symptoms need monitoring.

Schematic of the modality · Long-acting mono-pegylated interferon alfa · not a molecule; see the Cytokines & engineered cytokines page
Modality
Long-acting mono-pegylated interferon alfa
Mechanism
Type I interferon signalling suppresses the JAK2-mutant clone preferentially, with immunomodulatory and antiproliferative effects; every-2-week dosing.
Brand / code
Besremi
Medicare
Part B (clinician-administered)

Subcutaneous injection every two weeks; when administered in the clinic it is billed under Part B, and the label permits self-injection after training, in which case Part D plans may cover it. Confirm which benefit the plan applies.

Commercial insurance
covered with prior authorisation

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. Polycythaemia vera; some plans require hydroxyurea intolerance or failure first.

20% Part B coinsurance on a high-cost infusion adds up quickly: Medigap Plan G or N, Medicare Advantage maximum out-of-pocket, Medicaid dual eligibility, or a charity fund are the usual buffers.

Sources: Medicare.gov: Chemotherapy · Medicare.gov: Prescription drugs (outpatient, Part B). Not medical or financial advice; verify with your plan.

Not yet researchedSearch NICE
Notes
Licensed 2019 for polycythaemia vera without symptomatic splenomegaly; NICE appraisal outcome not verified. Check NICE.

Sources: NICE search: ropeginterferon alfa-2b. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.

Regulatory

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Approvals

RegionYearIndication
EU2019Polycythaemia vera without symptomatic splenomegaly
US2021Polycythaemia vera

Trials

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ClinicalTrials.gov · phase 2/3
refreshed 2026-09-09
23 studies5 recruiting14 Phase 211 Phase 3
Search “Ropeginterferon alfa-2b” on ClinicalTrials.gov →
Counts are from a name search and may include unrelated studies; up to 100 studies are summarised.

Recruiting now (live from ClinicalTrials.gov)

Recruiting trials near you · live from ClinicalTrials.gov
Ropeginterferon alfa-2b
intervention: Ropeginterferon alfa-2b
Open on ClinicalTrials.gov →

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Latest papers

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Latest papers · live from Europe PMC
Open in Europe PMC

Query for this drug: (TITLE:"Ropeginterferon alfa-2b" OR ABSTRACT:"Ropeginterferon alfa-2b" OR TITLE:"Besremi" OR ABSTRACT:"Besremi") 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 Ropeginterferon alfa-2b, not a curated reading list.

Connected

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