PDR Drug Update - November 2026

Maintaining Hematocrit Control in Polycythemia Vera

Polycythemia vera is a chronic Philadelphia chromosome-negative myeloproliferative neoplasm predominantly characterized by erythrocytosis, and frequently leukocytosis and thrombocytosis. Most patients harbor a JAK2 mutation, which drives dysregulated hematopoiesis. Clinical manifestations of polycythemia vera include symptoms such as fatigue, aquagenic pruritus, erythromelalgia, and splenomegaly. The major complication of the disorder is arterial or venous thrombosis, contributing to significant morbidity and mortality. It is also possible for patients to later progress to having myelofibrosis or acute myeloid leukemia.

The World Health Organization has established diagnostic criteria incorporating elevated hemoglobin or hematocrit, bone marrow panmyelosis, and JAK2 mutation status, with a subnormal serum erythropoietin level as a minor criterion. These diagnostic criteria should be distinguished from treatment recommendations. There is no cure for polycythemia vera, and therapeutic management primarily aims to reduce thrombotic risk and disease-related morbidity rather than eradicate the malignant clone.

Standard management includes therapeutic phlebotomy and low-dose aspirin, unless contraindicated. Cytoreductive therapy, including hydroxyurea or interferon-based treatment, is generally indicated for patients at high thrombotic risk and may be appropriate for selected patients with persistent symptoms or inadequate hematocrit control. Maintaining hematocrit below 45% is a central treatment objective. Some patients require repeated phlebotomies to maintain target hematocrit. Repeated procedures impose logistical and clinical burdens and can aggravate iron deficiency, potentially contributing to fatigue and other symptoms that can significantly reduce quality of life. These limitations underscore the need for therapies that achieve durable hematocrit control while reducing reliance on phlebotomy.

The FDA recently approved Mimrylo (rusfertide), the first hepcidin mimetic indicated for erythrocytosis in adults with polycythemia vera. Hepcidin regulates systemic iron availability by binding to ferroportin, limiting iron export from cells into circulation. Rusfertide mimics this pathway, restricting iron availability for hemoglobin synthesis and reducing red blood cell production. Administered subcutaneously, it offers a mechanism distinct from conventional cytoreductive therapies.

The phase 3 VERIFY trial evaluated rusfertide plus standard care against placebo plus standard care in patients requiring frequent phlebotomy. During weeks 20-32, 76.9% of patients receiving rusfertide required no phlebotomy, compared with 32.9% receiving placebo. Improvements in fatigue and disease-related symptom measures further suggest potential patient-centered benefits. Common adverse reactions included injection-site reactions and anemia. Platelet counts require monitoring because thrombocytosis can develop or worsen.

The most recent update to the National Comprehensive Cancer Network Guidelines for Myeloproliferative Neoplasms (Version 3.2026) includes rusfertide as a category 1 option across low- and high-risk polycythemia vera. When frequent phlebotomy is required, or a patient is intolerant of phlebotomy, rusfertide may be used instead of or alongside cytoreductive therapy. Importantly, it does not replace cytoreduction when treatment is needed to address leukocytosis, thrombocytosis, or other disease features.

Rusfertide represents a meaningful advance in managing polycythemia vera-associated erythrocytosis, particularly for patients whose hematocrit remains difficult to control or whose phlebotomy burden is substantial. However, reduced phlebotomy requirements should not be equated with proven prevention of thrombosis, improved survival, or disease modification. Longer-term evidence is needed to determine whether sustained hematocrit control with hepcidin-mimetic therapy translates into broader outcomes. For now, rusfertide expands the therapeutic toolkit, with its role individualized according to hematocrit control, treatment tolerance, and the patient's overall disease profile. Stay informed about emergent drug information, including hematological treatment options, by exploring PDR by ConnectiveRx. You can also stay current by using the official PDR app, mobilePDR, which is available for free from your preferred app store.

FDA New Approvals

Atebrioz

The FDA has approved Atebrioz (zilurgisertib) tablets to reduce the volume of total new heterotopic ossification in adults and pediatric patients 12 years and older with fibrodysplasia ossificans progressiva. Learn more about Atebrioz

Bravnetsa

The FDA has approved Bravnetsa (lutetium Lu 177 dotatate), a bioequivalent and therapeutically equivalent radiopharmaceutical to Lutathera (lutetium Lu 177 dotatate). Bravnetsa is indicated for the treatment of adult patients with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors, including foregut, midgut, and hindgut neuroendocrine tumors. Learn more about Bravnetsa

Emcitate

The FDA has approved Emcitate (tiratricol), a thyroid hormone receptor agonist, for the treatment of peripheral thyrotoxicosis in adult and pediatric patients with monocarboxylate transporter 8 deficiency. Learn more about Emcitate

Hibsago

The FDA has approved Hibsago (bepirovirsen) for the treatment of chronic hepatitis B virus (HBV) infection in combination with nucleos(t)ide analogue reverse transcriptase inhibitor (NRTI) therapy in adult patients without cirrhosis, receiving NRTI therapy for at least 6 months, who have suppressed HBV deoxyribonucleic acid, and with HBsAg levels ≤3000 IU/mL, as determined by an FDA-authorized test. Learn more about Hibsago

Hovilpri

The FDA has approved Hovilpri (pritelivir) tablets for adults with weakened immune systems who have mucocutaneous lesions caused by herpes simplex virus infection and have not responded to other therapies (acyclovir, valacyclovir, or famciclovir). Learn more about Hovilpri

Juvmo

The FDA has approved Juvmo (tavapadon) tablets as the first and only selective D1/D5 receptor agonist for the treatment of adults with Parkinson's disease. Learn more about Juvmo

Lyrfigtu

The FDA has approved Lyrfigtu (lirafugratinib) as a treatment option for patients with cholangiocarcinoma with FGFR2 fusion or other rearrangement. Learn more about Lyrfigtu

Onswik

The FDA has approved Onswik (insulin efsitora alfa-gobe), a once-weekly basal insulin, indicated along with diet and exercise to control high blood sugar in adults with type 2 diabetes. Onswik is designed to deliver steady basal insulin levels over a full seven days. Learn more about Onswik

FDA New Indications

Anktiva

The FDA has approved Anktiva (nogapendekin alfa inbakicept-pmln) in combination with Bacillus Calmette-Guérin (BCG) to include patients with BCG-unresponsive non-muscle-invasive bladder cancer with papillary-only tumors. Learn more about Anktiva

Aqneursa

The FDA has approved Aqneursa (levacetylleucine) for oral suspension to treat ataxia in adults and pediatric patients with ataxia-telangiectasia weighing at least 15kg. Learn more about Aqneursa

Camzyos

The FDA has approved Camzyos (mavacamten) for the treatment of symptomatic obstructive hypertrophic cardiomyopathy to improve functional capacity and symptoms in adult and pediatric patients weighing 30kg (66 lbs) or more. Learn more about Camzyos

Gazyva

The FDA has approved Gazyva (obinutuzumab) to reduce the risk of relapse in adult and pediatric patients 2 years of age and older with frequently relapsing or steroid-dependent childhood-onset idiopathic nephrotic syndrome who are in complete remission. Learn more about Gazyva

Jaypirca

The FDA has approved an additional indication for Jaypirca (pirtobrutinib), for the treatment of adult patients with previously untreated chronic lymphocytic leukemia or small lymphocytic lymphoma with no known 17p deletion. This approval allows for the use of Jaypirca as a first-line treatment for appropriate patients. Learn more about Jaypirca

Jemperli

The FDA has approved Jemperli (dostarlimab-gxly) as the first and only immunotherapy for adults with stage II and III microsatellite instability-high/mismatch repair deficient locally advanced rectal cancer. Learn more about Jemperli

Olumiant

The FDA has approved Olumiant (baricitinib), a once-daily pill, for the treatment of pediatric patients 12 years of age and older with severe alopecia areata. Learn more about Olumiant

Rhapsido

The FDA has approved Rhapsido (remibrutinib) as the first treatment for adults with symptomatic dermographism inadequately controlled by H₁ antihistamines, expanding its use beyond chronic spontaneous urticaria. Learn more about Rhapsido

Ryzumvi

The FDA has approved Ryzumvi (phentolamine) ophthalmic solution 0.75% for the treatment of presbyopia in adults. Learn more about Ryzumvi

Tecentriq

The FDA has approved Tecentriq (atezolizumab) and Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs) in combination with a fluoropyrimidine and oxaliplatin for the adjuvant treatment of stage III deficient DNA mismatch repair colon cancer, a type of tumor characterized by high mutation rates. This approval marks the twelfth indication for Tecentriq. Learn more about Tecentriq

Tukysa

The FDA has approved Tukysa (tucatinib) in combination with trastuzumab and pertuzumab for the maintenance treatment of adults with unresectable locally advanced or metastatic human epidermal growth factor 2-positive breast cancer following induction treatment. Learn more about Tukysa

Welireg + Lenvima

The FDA has approved the dual oral regimen of Welireg (belzutifan) plus Lenvima (lenvatinib) for the treatment of adult patients with advanced renal cell carcinoma with a clear cell component following a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor. Learn more about Welireg + Lenvima

Winrevair

The FDA has approved Winrevair (sotatercept-csrk) for the treatment of adults with pulmonary arterial hypertension (PAH, WHO Group 1 pulmonary hypertension) to improve exercise capacity and WHO functional class, and reduce the risk of clinical worsening events, including hospitalization for PAH, lung transplantation, and death. Learn more about Winrevair

FDA New Rx to OTC

Brytly

The FDA has approved Brytly (apraclonidine) ophthalmic solution 0.125% as an OTC treatment for eye redness due to minor irritation. Prior to this action, apraclonidine had only been available by prescription as a short-term adjunctive therapy to reduce elevated intraocular pressure (IOP) and to control and prevent postsurgical elevations in IOP that occur in patients after argon laser trabeculoplasty, argon laser iridotomy or Nd:YAG posterior capsulotomy. Learn more about Brytly

FDA New Formulations

Enspryng

The FDA has approved Enspryng (satralizumab-mwge) for the treatment of adults with thyroid eye disease (TED), providing patients with the first and only at-home subcutaneous treatment option. Enspryng can be administered by a person living with TED or a caregiver following training from a healthcare provider. Learn more about Enspryng

Evoxac

The FDA has approved an oral solution formulation of Evoxac (cevimeline HCl) for the treatment of symptoms of dry mouth in adults with Sjögren disease. Learn more about Evoxac

Weltruza

The FDA has approved Weltruza (olanzapine) for extended-release injectable suspension as the first and only once-monthly subcutaneous long-acting injectable formulation of olanzapine for the treatment of schizophrenia in adults, with no loading doses, no oral supplementation and no post-injection monitoring required. Learn more about Weltruza

Yusimry

The FDA has approved a high-concentration formulation of Yusimry (adalimumab-aqvh) as an interchangeable biosimilar to Humira (adalimumab). Learn more about Yusimry

Zilbrysq

The FDA has approved the first self-administered once-daily, autoinjector administration option for the treatment of generalized myasthenia gravis in adult patients who are anti-acetylcholine receptor antibody positive with Zilbrysq (zilucoplan). Learn more about Zilbrysq

FDA Recalls

Greenwich Rx Glutathione

Greenwich Rx is voluntarily recalling specific lots of its compounded glutathione to the consumer level. The product is being recalled due to potentially elevated endotoxin levels. Learn more about the Greenwich Rx glutathione recall

Otsuka Sodium Chloride

Otsuka ICU Medical LLC is issuing a voluntary recall for one lot of 0.9% sodium chloride injection, USP, 100mL single pack, to the user level, due to a potential mix-up. The affected lot of 0.9% sodium chloride Injection, USP (NDC: 0990-7984-23 Lot 1042188) may potentially contain the overwrap with labeling indicating it to be 0.9% sodium chloride injection, USP (NDC: 0990-7984-23) but the actual product within the overwrap may be potassium chloride injection, 10 mEq, (NDC 0990-7074-26) Lot 1035181. Learn more about the Otsuka sodium chloride recall

Par Health Argatroban

Par Health is recalling 22 lots of argatroban injection 250mg/2.5mL (100mg/mL) to the hospital/user level. This recall is being conducted due to the presence of particulate matter, identified as cellulose, polystyrene, polyethylene terephthalate, stopper material, and possibly stainless steel, that was detected in certain lots. Learn more about the Par Health argatroban recall

Par Health Brevital Sodium

Par Health is voluntarily recalling two lots of Brevital Sodium 500mg/vial CIV (methohexital sodium for injection, USP) to the hospital level. The product is being recalled due to the presence of particulate matter identified as cellulose. Learn more about the Par Health Brevital Sodium recall

Par Health Dexmedetomidine HCl

Par Health is voluntarily recalling two lots of dexmedetomidine HCl in 0.9% sodium chloride injection, 400 mcg/100mL (4 mcg/mL), to the hospital level. The product is being recalled due to the presence of particulate matter identified as cellulose or stopper material. Learn more about the Par Health dexmedetomidine HCl recall

November 2026