PegIFN in MPN: who and why
| MPN subtype . | Target population . | Why . | FDA/EMA approval . |
|---|---|---|---|
| Polycythemia vera | High-risk first line | • High rate of CHR • High rate of MR • Possible EFS improvement | Yes/yes Only for ropegINF-α2b |
| High-risk second line | • High rate of CHR • High rate of MR • Possible EFS improvement | Yes/yes Only for ropegINF-α2b | |
| Low risk | In only 1 study, compared to PHL + ASA: • Higher rate of CHR • Improvement in symptoms • Higher rate of MR | Yes/yes Only for ropegINF-α2b | |
| Pregnancy | • Reduced risk of miscarriage • Improved maternal and fetal outcomes | No/no | |
| Essential thrombocythemia | High-risk first line | • High rate of CHR • High rate of MR | No/no |
| High-risk second line | • High rate of CHR • High rate of MR | No/no Ongoing phase 3 studies with ropegINF-α2b | |
| Pregnancy | • Reduced risk of miscarriage • Improved maternal and fetal outcomes | No/no | |
| Myelofibrosis | Low risk and early stage (splenomegaly <6 cm BCM, no grade 3 fibrosis) | • Possible resolution of fibrosis • Possible MR | No/no Ongoing phase 2 studies with ropegINF-α2b |
| Prefibrotic myelofibrosis | • Possibly avoid disease progression to overt myelofibrosis | No/no Ongoing phase 2 studies with ropegINF-α2b |
| MPN subtype . | Target population . | Why . | FDA/EMA approval . |
|---|---|---|---|
| Polycythemia vera | High-risk first line | • High rate of CHR • High rate of MR • Possible EFS improvement | Yes/yes Only for ropegINF-α2b |
| High-risk second line | • High rate of CHR • High rate of MR • Possible EFS improvement | Yes/yes Only for ropegINF-α2b | |
| Low risk | In only 1 study, compared to PHL + ASA: • Higher rate of CHR • Improvement in symptoms • Higher rate of MR | Yes/yes Only for ropegINF-α2b | |
| Pregnancy | • Reduced risk of miscarriage • Improved maternal and fetal outcomes | No/no | |
| Essential thrombocythemia | High-risk first line | • High rate of CHR • High rate of MR | No/no |
| High-risk second line | • High rate of CHR • High rate of MR | No/no Ongoing phase 3 studies with ropegINF-α2b | |
| Pregnancy | • Reduced risk of miscarriage • Improved maternal and fetal outcomes | No/no | |
| Myelofibrosis | Low risk and early stage (splenomegaly <6 cm BCM, no grade 3 fibrosis) | • Possible resolution of fibrosis • Possible MR | No/no Ongoing phase 2 studies with ropegINF-α2b |
| Prefibrotic myelofibrosis | • Possibly avoid disease progression to overt myelofibrosis | No/no Ongoing phase 2 studies with ropegINF-α2b |
ASA, aspirin; BCM, below costal margin, EFS, event-free survival; EMA, European Medicine Agency; FDA, Food and Drug Administration; PHL, phlebotomy.