By David Wallace – September 23, 2026
Mimrylo (rusfertide) has been added as a Category 1 treatment option for both low- and high-risk polycythemia vera (PV) in the National Comprehensive Cancer Network’s updated guidelines. For patients who need frequent phlebotomies, the update is another reason to ask whether a medicine designed to control hematocrit could fit their care plan.
The recommendation appears in the NCCN Guidelines for Myeloproliferative Neoplasms, Version 3.2026, updated September 18. Takeda’s September 21 announcement and CancerNetwork’s September 22 report both note that Mimrylo is the only treatment with a Category 1 recommendation across both PV risk groups. Category 1 means high-level evidence and broad panel agreement that the option is appropriate.
Why hematocrit control still matters
PV is a chronic blood cancer in which the body makes too many red blood cells, raising blood thickness and clot risk. Keeping hematocrit below 45% remains the central treatment goal. Even so, Takeda cites estimates that roughly 78% of patients still have uncontrolled hematocrit despite phlebotomy and cytoreductive therapy, with a much higher risk of major cardiovascular events when hematocrit stays high.
How Mimrylo fits into PV treatment
Mimrylo is a first-in-class weekly subcutaneous injection that mimics hepcidin, a hormone that helps regulate iron. By limiting iron available for red blood cell production, it aims to bring hematocrit down and keep it there.
According to CancerNetwork’s summary of the guidelines:
- Low-risk PV: Rusfertide may be used instead of, or alongside, cytoreductive therapy when frequent phlebotomy or difficulty tolerating phlebotomy is the reason for additional treatment.
- High-risk PV: Rusfertide may be added to cytoreductive therapy when hematocrit remains hard to control or phlebotomies are still required.
Cytoreductive therapy means medication used to reduce blood-cell production. Rusfertide does not replace it when it is still needed to manage elevated white blood cells, platelets, or other disease-related features.
What the evidence shows
The FDA approved Mimrylo on August 28, 2026, for erythrocytosis (excess red blood cells) in adults with PV. NCCN’s inclusion drew on the phase 3 VERIFY study and the phase 2 REVIVE study (more than 360 patients combined). In VERIFY, Mimrylo plus current therapy more than doubled clinical response rates versus placebo plus current care, with better hematocrit control, fewer phlebotomies, and less patient-reported fatigue. About 77% of Mimrylo-treated patients needed no phlebotomy over a key 32-week window, compared with about 33% on placebo.
Common side effects included injection-site reactions and anemia. Mimrylo can also raise platelet counts, so blood-count monitoring matters.
What patients can take from this update
For patients whose weeks still revolve around phlebotomy appointments, this supports a practical next conversation: Could rusfertide help with hematocrit control, and how would it fit with current treatment? The choice remains individual. Our Mimrylo FDA approval coverage explains the medicine, trial results, and questions to bring to your healthcare team.
