[Posted 19/May/2022]

AUDIENCE: Hematology, Family Medicine

KEY FINDINGS: Interferon alfa-2b is approved in treatment-naive patients and for patients with hydroxyurea resistance or intolerance, and ruxolitinib, a Janus kinase 1/2 inhibitor is exclusively approved for second-line treatment.

BACKGROUND: The clinical triumvirate of polycythemia vera include disease-related symptoms, vascular events, and transformation to myelofibrosis or blast phase.

DETAILS: Regulatory approval for polycythemia vera directed therapy is dependent on the achievement of a complete hematological response or phlebotomy associated goals (short-term clinical trial endpoints) that might not affect the most clinically relevant outcome measures of thrombosis, progression, and overall survival due to longer time to event, and lower incidence, which make polycythemia vera a challenging disease to evaluate in prospective trials. Although hydroxyurea is the mainstay of treatment in patients with polycythemia vera, approximately 15% of patients develop resistance or intolerance, which is deemed an adverse prognostic factor with higher risk for death (hazard ratio [HR] 5.6, 95% CI 2.7-11.9; p<0.001) and transformation to myelofibrosis or blast phase (HR 6.8, 3.0-15.4; p<0.001).

Copyright © Elsevier Ltd. All rights reserved.

Source: Venugopal, S. and Mascarenhas, J. (2022). Ruxolitinib In Patients With Polycythemia Vera With Hydroxyurea Resistance Or Intolerance. The Lancet. Published: May 18, 2022. DOI: 10.1016/S2352-3026(22)00139-9.

[Posted 24/Jun/2026]

AUDIENCE: Infectious Disease, Internal Medicine

KEY FINDINGS:

• FDA approved the first generic form of baloxavir marboxil tablets.
• Approved for patients aged 5 years and older.
• Indications include acute uncomplicated influenza treatment and post-exposure prophylaxis.
• Treatment eligibility requires symptom duration of no more than 48 hours.
• Contraindicated in patients with hypersensitivity to baloxavir marboxil or formulation ingredients.
• Common adverse effects: diarrhea, bronchitis, nausea, sinusitis, and headache.
• In the U.S., nine out of 10 prescriptions filled are for generic drugs.
• Approval granted to Norwich Pharmaceuticals, Inc.

BACKGROUND: The U.S. Food and Drug Administration (FDA) announced approval of the first generic version of baloxavir marboxil tablets, previously marketed as Xofluza. This approval introduces the first single-dose generic option for both treatment and post-exposure prophylaxis of influenza. The approval was issued ahead of the 2026–2027 influenza season with the objective of expanding access to generic medications and supporting public health preparedness.

DETAILS: Generic baloxavir marboxil tablets are approved for use in patients aged 5 years and older. Indications include treatment of acute uncomplicated influenza in individuals who have experienced symptoms for no more than 48 hours and who are either otherwise healthy or at elevated risk for influenza-related complications. The medication is also approved for post-exposure prophylaxis following contact with an infected individual.

The drug is contraindicated in patients with known hypersensitivity to baloxavir marboxil or any formulation components. Safety considerations include warnings regarding increased incidence of treatment-emergent resistance in patients younger than 5 years of age.

Common adverse effects reported include diarrhea, bronchitis, nausea, sinusitis, and headache.

FDA approval of generic baloxavir marboxil provides an additional therapeutic option for influenza management through a single-dose regimen. Increased availability of generic alternatives may support broader patient access and affordability while maintaining treatment availability before the upcoming flu season.

Copyright © Skyscape Editorial Team. All rights reserved.

Source: News Release: FDA Approves First Single-Dose Generic Treatment for Influenza.. FDA. Published: June 17, 2026.

A Phase 3, Multicentre, Randomised, Double-Blind, Placebo-Controlled Tria.

[Posted 23/Jun/2026]

AUDIENCE: Oncology, Internal Medicine

KEY FINDINGS: The addition of aglatimagene plus valacyclovir to standard radiotherapy improved disease-free survival in patients with localised prostate cancer without increasing clinically significant toxicity compared to placebo.

BACKGROUND: Approximately 30% of men with localised prostate cancer who undergo radiotherapy with curative intent experience disease recurrence, which often leads to the need for salvage therapies that carry significant toxicity. Previous research indicated that aglatimagene besadenovec (CAN-2409) demonstrates synergy with radiation and induces immune-mediated cytotoxicity in prostate cancer patients. This study evaluated whether adding aglatimagene plus the prodrug valacyclovir to standard-of-care external beam radiotherapy (EBRT) could improve disease-free survival.

This was a phase 3, randomised, double-blind, placebo-controlled study conducted at 51 centres in the USA and Puerto Rico. Eligible patients (aged >=18 years, ECOG score 0-2) with intermediate- or high-risk prostate cancer were randomised (2:1) to receive either intraprostatic aglatimagene (5 x 10¹¹} viral particles) plus valacyclovir or a placebo plus valacyclovir, alongside standard-of-care EBRT. The primary endpoint was disease-free survival in the intent-to-treat population. Safety was assessed in all patients who received at least one injection. Between Feb 21, 2012, and Sept 9, 2021, 745 men were randomly assigned to the aglatimagene group (n=496) or the placebo group (n=249). After a median follow-up of 50.3 months, median disease-free survival was not reached in the aglatimagene group, while it was 86.1 months in the placebo group (hazard ratio 0.70, 95% CI 0.52–0.94; P=0.016). Grade 3 or worse treatment-emergent adverse events (TEAEs) occurred in 40 (8%) of 479 patients in the aglatimagene group and 17 (7%) of 232 in the placebo group, with acute kidney injury being the most common grade 3 or worse TEAE in both cohorts (2%). No treatment-related deaths were reported. DETAILS:

Copyright © Skyscape Editorial Team. All rights reserved.

Source:DeWeese, T., Manzanera, A., Sylvester, J. et al. Aglatimagene Besadenovec (CAN-2409) With Radiotherapy for Patients With Localised Prostate Cancer: A Phase 3, Multicentre, Randomised, Double-Blind, Placebo-Controlled Trial. The Lancet Oncology. 2026; 27(6): 673-685. Published: June 22, 2026. DOI: XXXX

A Single-Centre, Open-Label, Phase 2 Trial

[Posted 16/Jun/2026]

AUDIENCE: Hematology, Oncology

KEY FINDINGS: Adverse events were few, probably due to organ sparing by total marrow and lymphoid irradiation. Total marrow and lymphoid irradiation 2000 cGy could be safely delivered in combination with high-dose etoposide and cyclophosphamide. The regimen was associated with encouraging 2-year progression-free survival rates.

BACKGROUND: Total marrow and lymphoid irradiation delivers augmented doses of radiation to the bone marrow and lymph nodes while maintaining low doses to vital organs. We aimed to assess the effectiveness of combining total marrow and lymphoid irradiation (2000 cGy to bone marrow and lymph nodes) with high-dose cyclophosphamide and etoposide as a conditioning regimen before allogeneic haematopoietic cell transplantation (HCT) in patients with relapsed or refractory acute leukaemia.

DETAILS: This single-centre, open-label, phase 2 trial with an initial six-patient safety lead-in, conducted in the USA, enrolled patients aged between 16 and 60 years with relapsed or refractory acute myeloid leukaemia or acute lymphoblastic leukaemia. Total marrow and lymphoid irradiation was given on days -9 to -5, etoposide 60 mg/kg on day -4, and cyclophosphamide 100 mg/kg on day -2. Bone marrow or peripheral blood stem cells from sibling or matched or one allele mismatched unrelated donors were infused on day 0. Graft versus host disease prophylaxis consisted of tacrolimus and sirolimus. The primary endpoint for the initial safety lead-in segment was toxicity and for the phase 2 study was 2-year progression-free survival. All patients who began treatment were included in the analysis. This trial is registered with ClinicalTrials.gov, NCT02094794, and is closed to accrual. Between May 9, 2014, and Mar 5, 2024, 107 patients were enrolled and screened for eligibility. One did not meet eligibility criteria (uncontrolled cytomegalovirus). 106 received conditioning radiation and HCT per protocol. Median follow-up was 1·8 years (IQR 0·6-3·0) for all patients and 3·1 years (2·1-4·9) for patients who were alive at last contact. None of the six patients in the safety lead-in experienced unacceptable toxicity. 49 (46%) of 106 patients were female and 57 (54%) were male. 72 (68%) of patients were White and 22 (21%) were Asian or Pacific Islander. The 2-year estimate of progression-free survival in all patients was 34% (95% CI 25-43%). The most common grade 3-4 adverse events were cytopenias 96 (91%), metabolic disorders 83 (78%), oral mucositis 45 (42%), diarrhoea 25 (24%), nausea 21 (20%), and palmar-plantar erythrodysesthesia syndrome 11 (10%). One patient died of sinusoidal obstruction syndrome attributed to the conditioning regimen.

Copyright © Elsevier Ltd. All rights reserved.

Source: Stein, A., Wang, Y., Malki, M., et al. Total Marrow and Lymphoid Irradiation in Combination With Cyclophosphamide and Etoposide Before Haematopoietic Cell Transplantation for Relapsed or Refractory Acute Leukaemia: A Single-Centre, Open-Label, Phase 2 Trial. The Lancet Haematology. 2026; 13: e365-e375. Published: May, 2026. DOI: 10.1016/S2352-3026(26)00014-1.

[Posted 15/Jun/2026]

AUDIENCE: Infectious Disease, Internal Medicine

KEY FINDINGS: Study results suggest that clinicians should initiate antiviral chemoprophylaxis for at least 70% of eligible NH residents within 2 days of outbreak detection to lower risk of hospitalization.

BACKGROUND: Influenza outbreaks in nursing homes (NHs) pose a substantial threat to older adults, often resulting in morbidity and mortality. The Centers for Disease Control and Prevention (CDC) and the Infectious Diseases Society of America (IDSA) recommend prompt postexposure prophylaxis, also termed chemoprophylaxis or prophylaxis with oseltamivir, for all residents who are not ill to limit influenza spread in NHs. Purpose of the study is to examine whether initiating antiviral chemoprophylaxis for 70% or more of eligible NH residents within 2 days of influenza outbreak detection is associated with lower all-cause mortality and hospitalization at 14 and 30 days.

DETAILS: Retrospective cohort study using a sequential cluster-randomized target trial emulation and randomize-censor-weight approach for influenza outbreaks (September 1, 2018-May 31, 2022) in 12 US NH corporations. Eligibility criteria were age 18 years or older, present on the outbreak-detection day, no antiviral use in the preceding 7 days, no influenza in the past 14 days, and complete baseline data. Residents were followed up until hospitalization or death, an NH discharge to a nonacute-care location, or the end of follow-up. Data were analyzed from February 2023 to January 2026.

Exposures: Intensive antiviral chemoprophylaxis with oseltamivir (>=70% of eligible residents within 2 days of outbreak detection) or nonintensive antiviral chemoprophylaxis (0% to <70% of eligible residents).

Outcomes were all-cause death and hospitalizations within 14 and 30 days of outbreak detection. Discrete-time hazard models with pooled logistic regression were applied to estimate weighted risks, risk differences (RDs), and risk ratios (RRs).

Among 404 outbreaks in 318 NHs, 35,086 resident-trial observations (29,683 residents; median age 78 [IQR, 68- 86] years; 60% women; 81% White; 76% vaccinated) met eligibility criteria. Intensive oseltamivir prophylaxis was randomized to 17,155 observations; 17,931 were randomized to nonintensive care. At 14 days, intensive prophylaxis vs nonintensive yielded an RD of -0.06% (95% CI, -0.73% to 0.93%) and an RR of 0.96 (95% CI, 0.56-1.57) for death, and an RD of -0.96% (95% CI, -1.78% to -0.19%) and an RR of 0.79 (95% CI, 0.64-0.96) for hospitalization. At 30 days, the hospitalization differences persisted but were less precise and there continued to be no difference in death.

Copyright © American Medical Association. All Rights Reserved.

Source: Silva, J. B. B., Hsieh, H. T., Howe, C. J., et al. Prompt and Intensive Antiviral Chemoprophylaxis in Nursing Home Influenza Outbreaks. JAMA Internal Medicine.. 2026; 186(6): 714-722. Published: June, 2026. DOI: 10.1001/jamainternmed.2026.0401

A Nationwide Analysis

[Posted 12/Jun/2026]

AUDIENCE: Hospice & Palliative Nursing, Oncology

KEY FINDINGS: Hospice involvement was associated with lower use and reduced exposure to broad-spectrum antibiotics among patients with cancer near the end of life. These findings support the alignment of end-of-life treatment decisions with the comfort-oriented goals of hospice care.

BACKGROUND: Authors aimed to compare broad-spectrum antibiotic use between hospice and non-hospice patients with cancer at the end of life using nationwide data from Korea.

DETAILS: In this retrospective cohort study, authors analyzed the Korean National Health Insurance Service data of adult patients with cancer who died between 2018 and 2021. Hospice users were defined as patients who received inpatient, home-based, or consultation-based hospice care before death. Authors applied propensity score matching (1:2) to balance the baseline characteristics of the hospice and non-hospice groups. Broad-spectrum antibiotic use, including anti-pseudomonal penicillins, anti-pseudomonal cephalosporins, carbapenems, and glycopeptides, was assessed during the last 3 months of life using prescription proportions and days of therapy per 1,000 patient-days. After matching, 38,102 hospice and 75,736 non-hospice users were analyzed. During the last 3 months of life, 74.6% of hospice and 79.0% of non-hospice users received at least one broad-spectrum antibiotic (P<0.001). The proportion of patients receiving broad-spectrum antibiotics was generally lower among hospice users across all time intervals (P<0.001), and the number of days of therapy was also lower, with the largest differences observed during the final week and last 3 days of life. Subgroup analyses showed the highest antibiotic exposure among patients with hematologic and pancreatobiliary cancers, particularly in the non-hospice group.

Copyright © Journal of Hospice and Palliative Care. All rights reserved.

Source: Jeung, Y. S., Kim, G. J., Yu, J., et al. Comparison of Broad-Spectrum Antibiotic Use According to Hospice Utilization Among Patients with Cancer at the End of Life in South Korea: A Nationwide Analysis. v. 2026; 29(2): 41-50. Published: June, 2026. DOI: 10.14475/jhpc.2026.29.2.41