The June cycle also includes a significant update to the existing recommendation for nusinersen in spinal muscular atrophy, as well as a positive second appraisal for a CAR-T cell therapy in large B-cell lymphoma — a treatment pathway that continues to expand within the NHS.

Oncology

Tivdak recommended for cervical cancer

Tisotumab vedotin (Tivdak), an antibody-drug conjugate developed by Genmab and Pfizer (via Seagen), received a positive NICE recommendation on 11 June 2026 for previously treated recurrent or metastatic cervical cancer. Tivdak targets tissue factor, a protein highly expressed on cervical cancer cells, and delivers a microtubule-disrupting payload directly to tumour cells. The approval addresses a population with limited options following progression on first-line platinum-based chemotherapy.

Libtayo recommended for non-small cell lung cancer

Cemiplimab (Libtayo), developed by Regeneron, was recommended on 16 June 2026 for previously untreated non-small cell lung cancer (NSCLC) in patients whose tumours express PD-L1. Libtayo is a PD-1 checkpoint inhibitor that restores the immune system’s ability to recognise and destroy cancer cells. The recommendation offers a further immunotherapy option in first-line NSCLC alongside existing PD-1 and PD-L1 inhibitors already available on the NHS.

Darzalex Faspro quadruplet recommended for multiple myeloma

NICE recommended the four-drug combination of daratumumab SC, lenalidomide, bortezomib, and dexamethasone (D-VRd; Darzalex Faspro, Revlimid, Velcade) on 24 June 2026 for newly diagnosed multiple myeloma. Submitted by Janssen Biotech, this subcutaneous daratumumab-based quadruplet regimen builds on the established VRd backbone by adding the anti-CD38 monoclonal antibody daratumumab, which has consistently demonstrated improved response rates and progression-free survival in myeloma. The approval positions D-VRd as a potential new standard of care for eligible transplant-eligible and ineligible patients.

Hansizhuang recommended for extensive-stage small cell lung cancer

Serplulimab (Hansizhuang), in combination with chemotherapy and submitted by Shanghai Henlius Biotech and Fosun Pharma, received a positive recommendation on 18 June 2026 for extensive-stage small cell lung cancer (ES-SCLC). Small cell lung cancer is an aggressive malignancy with a historically poor prognosis, and first-line chemoimmunotherapy has become the standard approach following earlier immunotherapy approvals in this setting. Serplulimab is an anti-PD-1 antibody, and its recommendation provides a further immunotherapy option for patients presenting with extensive disease.

Imfinzi plus FLOT chemotherapy recommended for gastric and gastro-oesophageal junction cancer

Durvalumab (Imfinzi) in combination with FLOT chemotherapy (fluorouracil, leucovorin, oxaliplatin, and docetaxel) was recommended by NICE on 3 June 2026 as a neoadjuvant and adjuvant treatment for resectable gastric cancer and gastro-oesophageal junction cancer (GEJC). Developed by AstraZeneca, the perioperative regimen adds PD-L1 blockade to an established chemotherapy backbone, reflecting evidence that immunotherapy can improve surgical outcomes and reduce the risk of recurrence in patients with potentially curable disease.

Breyanzi receives positive recommendation for diffuse large B-cell lymphoma

Lisocabtagene maraleucel (Breyanzi), a CD19-directed CAR-T cell therapy developed by Bristol Myers Squibb (via Juno Therapeutics and Celgene), received a positive second appraisal recommendation on 3 June 2026 for relapsed or refractory diffuse large B-cell lymphoma (DLBCL). CAR-T therapies represent a complex and highly personalised treatment modality in which a patient’s own T cells are engineered to recognise and destroy cancer cells. The updated recommendation reflects revised cost-effectiveness evidence and expands NHS access to this potentially curative one-time treatment for patients who have failed two or more prior lines of therapy.

Respiratory & Cardiovascular

Nucala recommended for eosinophilic COPD

Mepolizumab (Nucala), developed by GSK, received a positive recommendation on 17 June 2026 for eosinophilic chronic obstructive pulmonary disease (COPD). Nucala is an anti-interleukin-5 monoclonal antibody already established in severe eosinophilic asthma, and this approval extends its indication to a subset of COPD patients characterised by elevated blood eosinophil counts. It represents an important development in COPD management, which has traditionally relied on bronchodilators and inhaled corticosteroids, by targeting an underlying inflammatory mechanism in eligible patients.

Winrevair recommended for pulmonary arterial hypertension

Sotatercept (Winrevair), developed by Acceleron and Merck, received a positive NICE recommendation on 3 June 2026 for pulmonary arterial hypertension (PAH). Sotatercept is an activin signalling inhibitor — a first-in-class mechanism of action in PAH — that addresses vascular remodelling, the underlying pathological process driving the progressive increase in pulmonary artery pressure that characterises this condition. Current PAH therapies largely target vasodilation; sotatercept’s distinct mechanism makes it a meaningful addition to the treatment armamentarium, particularly in combination with existing background therapy.

Nexlizet recommended for dyslipidaemia

The combination of bempedoic acid and ezetimibe (Nexlizet), submitted by Esperion Therapeutics and Daiichi Sankyo, was recommended on 24 June 2026 for dyslipidaemia in patients unable to tolerate statins or with an inadequate response to statin therapy. Bempedoic acid inhibits ATP-citrate lyase, an enzyme upstream of HMG-CoA reductase in the cholesterol biosynthesis pathway, while ezetimibe reduces intestinal cholesterol absorption. The combination provides a non-statin LDL-lowering option for a patient group that includes those with statin intolerance, an issue frequently encountered in clinical practice.

Hepatology & Gastroenterology

Livdelzi recommended for primary biliary cholangitis

Seladelpar (Livdelzi), developed by Gilead Sciences and CymaBay Therapeutics, received a positive recommendation on 24 June 2026 for primary biliary cholangitis (PBC), a rare chronic autoimmune liver disease that can lead to cirrhosis if inadequately treated. Seladelpar is a selective PPAR-delta agonist that reduces the production of bile acids and suppresses biliary inflammation. The recommendation is significant for patients who have had an inadequate response to or cannot tolerate ursodeoxycholic acid, which has long been the only licensed first-line treatment for PBC in the UK.

Neurology & Paediatrics

Spinraza recommendation updated for spinal muscular atrophy

Nusinersen (Spinraza), developed by Biogen and Ionis Pharmaceuticals, received an updated NICE recommendation on 4 June 2026 for spinal muscular atrophy (SMA). SMA is a rare and often severe inherited neuromuscular disease caused by mutations in the SMN1 gene. Spinraza was among the first disease-modifying treatments to be approved for SMA and works by modifying splicing of the SMN2 gene to increase production of functional SMN protein. The updated recommendation likely reflects revised clinical or cost-effectiveness evidence, potentially expanding eligible patient groups or amending existing access criteria.

Terminated Appraisals

Inluriyo appraisal terminated for ER-positive breast cancer

The appraisal of imlunestrant (Inluriyo), an oral selective oestrogen receptor degrader (SERD) submitted by Eli Lilly and Loxo Oncology, was terminated on 18 June 2026 for oestrogen receptor-positive, HER2-negative breast cancer with ESR1 mutation. ESR1 mutations are a recognised mechanism of resistance to aromatase inhibitors and represent a clinically important unmet need. The reasons for termination were not specified in the available data, though terminated appraisals typically reflect a withdrawal by the company or an inability to agree a managed access arrangement.

Anktiva appraisal terminated for BCG-unresponsive bladder cancer

The appraisal of nogapendekin alfa inbakicept (Anktiva), submitted by ImmunityBio and Accord Healthcare for BCG-unresponsive non-muscle-invasive bladder cancer, was terminated on 4 June 2026. BCG-unresponsive disease represents a challenging clinical situation in which patients have failed intravesical BCG immunotherapy — the standard treatment for high-risk non-muscle-invasive bladder cancer — and face a choice between radical cystectomy or further bladder-sparing treatments. The termination leaves this patient population without a new approved option via NICE at this time.

Decisions referenced carry NICE Positive 1, NICE Positive 2, NICE Update 1, or Terminated status, issued between 3–24 June 2026. This article is based on data from the NICE Technology Appraisal Programme for England and Wales.

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The warning label currently required on alcohol containers in the United States has not changed since its adoption in 1988, despite new evidence linking alcohol to several diseases. The label states the risks of drinking during pregnancy and while driving or operating machinery and warns generally that drinking alcohol “may cause health problems.” The label often goes unnoticed and unremembered by consumers.

“We wanted to test whether new warnings could better inform consumers about alcohol’s harms and better encourage people to consider cutting back on their drinking,” says lead author Anna H. Grummon, Ph.D., M.S.P.H., assistant professor at the Stanford University School of Medicine. The study was conducted as part of a larger project co-led with Marissa G. Hall, Ph.D., associate professor at the University of North Carolina.

Designed to compare the effects of differently worded and designed warning labels, the study recruited a nationally representative sample of 1,036 adults of legal drinking age (21 and older) who reported drinking at least once a week.

Participants viewed 10 messages — one control, eight new warning labels, and the current U.S. warning label — in random order. They then rated each message on how well it encouraged them to drink less alcohol, reminded them of alcohol’s harms, and informed them of something new.

“Each participant rated multiple warnings covering a range of health harms — such as cancer, liver disease, hypertension, and dementia, among others — so we could make direct, apples-to-apples comparisons between them,” says Grummon.

All the new alcohol warnings in the study outperformed the current U.S. warning label, but those highlighting cancer risk were particularly effective. This finding is notable as policymakers in the United States and abroad debate whether to adopt a cancer warning on alcohol products.

“Ireland, for example, is set to require cancer warnings on alcohol containers in the coming years, and Alaska already requires a cancer warning to be posted in bars, restaurants, and liquor stores where alcohol is sold,” says Grummon. “Our findings suggest these policies could help people understand the risks of drinking and potentially reduce consumption.”

Study participants also rated the effectiveness of warning icons and label design. Triangles and octagons were perceived as more effective and attention-grabbing than other icons, such as a magnifying glass.

More research is underway. Grummon and Hall are currently running a randomized trial to test whether new alcohol warnings effectively lead people to drink less. The study will also measure whether the warnings improve knowledge of alcohol-related harms over time.

“We know from tobacco control that well-designed warnings can inform consumers and encourage healthier choices,” says Grummon. “Given that alcohol-related deaths are increasing, we hope policymakers will consider whether updating alcohol warnings should be part of a broader strategy to address alcohol-related harms.”
—–
Grummon, A. H., Lee, C. J. Y., Campos, A. D., Lazard, A. J., Brewer, N. T., Whitesell, C., Ruggles, P. R., Greenfield, T. K., & Hall, M. G. (2026). New alcohol warnings outperform the current U.S. warning in a national survey experiment. Journal of Studies on Alcohol and Drugs, 87(3), 433-443. https://doi.org/10.15288/jsad.25-00226

By W.B. Kagan

image: “Government warning” alcohol label

View more Credit: Journal of Studies on Alcohol and Drugs

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Oral contraceptive pills (OCPs) are commonly used for contraception, but their long-term effects on oxidative stress, lipid profiles, and liver function remain unclear. This study aimed to evaluate the impact of intermediate-term OCP use (Yasmin) on oxidative stress, lipid profile, and liver function, with particular emphasis on antioxidant markers, lipid metabolism, and hepatic enzyme activity, to better understand the potential metabolic and hepatic effects.

Methods

A case-control study was conducted in Maysan Governorate, Iraq, involving 150 women (100 OCP users and 50 non-users). Blood samples were collected from Al-Sadr Teaching Hospital and a specialized clinic between February and April 2023. Serum levels of antioxidants, lipids, and liver enzymes were measured using biochemical assays.

Results

OCP users had significantly lower levels of glutathione peroxidase vitamin E and uric acid (p < 0.001) compared to non-users. Lipid profiles showed that OCP users had higher levels of triglyceride and low-density lipoprotein (p < 0.05), whereas total cholesterol was significantly higher in non-users (p < 0.05). Liver enzyme activity, including alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, and total serum bilirubin, did not show statistically significant differences (p > 0.05). Longer duration of OCP use was significantly negatively correlated with vitamin E levels (r = −0.67), glutathione peroxidase activity (r = −0.56), uric acid levels (r = −0.45) and high-density lipoprotein (r = −0.54). Positive correlations were found between the duration of OCP use and total cholesterol (r = 0.62), triglyceride (r = 0.58), low-density lipoprotein (r = 0.60), and liver enzymes alanine aminotransferase (r = 0.66) and aspartate aminotransferase (r = 0.64).

Conclusions

Intermediate-term OCP use was associated with changes in oxidative stress and lipid metabolism, potentially increasing cardiovascular and metabolic risks. Regular monitoring of these parameters is recommended for OCP users.

Full text:

https://www.xiahepublishing.com/2472-0712/ERHM-2024-00035

The study was recently published in the Exploratory Research and Hypothesis in Medicine.

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The study in Cellular and Molecular Gastroenterology and Hepatology found that chlorcyclizine, a decades-old allergy medication, could potentially treat erythropoietic protoporphyria (EPP), a condition that creates extreme skin light sensitivity and can produce toxic levels of protoporphyrin in the liver, bone marrow, red cells, and plasma.

“There is an unmet need for these patients,” said Bishr Omary, senior vice chancellor for academic affairs and research at Rutgers Health and senior author of the study. “The primary treatment for patients with severe liver damage is liver transplantation, which is a major and life-saving surgery that depends on available donor organs.”

EPP is a rare condition, affecting an estimated 4,000 people in the U.S. Of those, only a small percentage suffer enough liver damage to require transplantation. It is unlikely, therefore, that any company will develop a drug to treat the condition, which is why Omary and his colleagues tested existing medications.

The research team screened more than 2,500 compounds, including many FDA-approved drugs, in a zebrafish larvae EPP experimental system previously described by Omary’s lab. The tiny fish allow researchers to visualize the buildup of toxic compounds easily and test potential treatments.

“The zebrafish are transparent at their larval stage, and that allows us to quantify and visualize the porphyrin, which is fluorescent,” said Ning Kuo, the first author of the study who worked with Omary at the University of Michigan, then Rutgers before moving to the University of California, San Diego to pursue her PhD. “It was easy to evaluate each treatment under the microscope. If I saw glowing porphyrin, the treatment didn’t work. If I didn’t, the treatment had enabled the liver to excrete it into the fish culture medium.”

When the researchers tested chlorcyclizine in mice with EPP, they found that female mice, but not male mice, experienced reduced hepatic protoporphyrin accumulation and liver injury, decreased protoporphyrin in bone marrow and red cells and increased protoporphyrin excretion in stool. This sex-specific effect appears related to how quickly males metabolize the drug.

“In rats, chlorcyclizine is metabolized eight times higher in male versus female livers,” said Omary. “Fortunately, we’re not aware of similar chlorcyclizine metabolism differences in humans.”

The study team, which included one researcher from Michigan, replicated their findings using an independent toxin-induced EPP mouse model. They also showed in EPP liver cell culture models that the histamine pathway promotes porphyrin accumulation, which is blocked by the over-the-counter antihistamine drug classes that treat allergy (e.g., chlorcyclizine or fexofenadine) or that limit acid production (e.g., cimetidine or ranitidine).

Detailed analysis showed that chlorcyclizine appears to work through multiple mechanisms, including helping the liver clear toxic porphyrin buildup and reducing inflammation. It also decreased the presence of mast cells, a type of immune cell that produces histamine.

For EPP patients, the findings could eventually lead to a much simpler treatment option than transplantation by preventing liver damage at a much earlier stage. The antihistamine allergy drugs have been used safely for decades, which could help speed the path to clinical trials for this new use.

The researchers hope to secure support for a clinical trial to test the effectiveness of chlorcyclizine in EPP patients for both liver and skin involvement. A phase 2 clinical trial is already underway, testing the antacid cimetidine for treating the skin manifestations of EPP. It is possible that the different antihistamines may act additively or synergistically.

“Given their well-established safety, we hope to fast-track trials of chlorcyclizine either alone or in combination with cimetidine,” Kuo said.

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Hepatic encephalopathy is the loss of brain function that occurs in people with severe liver disease. The condition is associated with high morbidity and mortality. The drug treatment rifaximin is commonly used to treat hepatic encephalopathy, yet treatment retention remains low.

“Our research demonstrates that the cost of rifaximin is too high in the United States. Individuals with scarred livers, who have a higher out-of-pocket cost, are more likely to not fill their prescription for their medication, which can result in falls, hospitalizations and other poor outcomes,” said Elizabeth Aby, MD, an assistant professor at the University of Minnesota Medical School and transplant hepatologist at M Health Fairview. “Clinicians and policy makers need to be aware of the impact that out-of-pocket costs have on patients’ medication adherence for rifaximin. Active measures must be taken to address this issue.”

The study included more than 6,800 patients with cirrhosis — a condition where the liver is scarred from long term damage — and hepatic encephalopathy. The research team’s analysis found patients who are younger and have metastatic cancer or depression are less likely to take their medication.

The research team suggests clinicians screen patients for financial insecurity and the potentially harmful effect the high cost of treatment could have on the patient, as well as involving social workers and financial assistance early. Additionally, further steps are needed to lower the cost of the drug.

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In a dietary analysis involving over 4,500 adults, drinking more than 3 cups of coffee (versus none) was associated with a 0.9 kPa reduction (95% CI -1.6 to -0.1, P=0.03) and with a reduced odds of liver stiffness (≥9.5 kPa; OR 0.4, 95% CI 0.2-1.0, P=0.05).

For this study 4,510 participants (mean age 48 years) from the National Health and Nutrition Examination Survey (NHANES) were evaluated. They underwent two 24-hour dietary recall exams and transient elastography investigations. Hepatitis patients were excluded.

The main outcome evaluated the quantity of coffee consumed and its association with liver stiffness measurements (LSM), with a ≥9.5 kPa considered a threshold for advanced fibrosis. Controls included those who reported tea and decaffeinated coffee consumption.

About three-quarters of the participants were overweight or obese and about half engaged in physical activity. Comorbidities included diabetes (11%) and chronic liver disease (5%). About 63% were white and 23% consumed a minimum of two daily alcoholic drinks. Most participants (n=3,797) had LSM values below 7.0 kPa, while 415 had values ranging from 7 to 9.5 kPa, and 298 had values of 9.5 kPa or above.

Adjusting for the consumption of sugar-sweetened beverages and Healthy Eating Index-2015 scores, coffee consumption was still associated with a reduction of LSM (OR 0.4, 95% CI 0.1-0.9, P=0.03).

The analysis had several limitations, the researchers acknowledged, including the potential for unmeasured confounding, recall bias, and the limited dietary data.

One explanation for the findings could be that caffeine reduces fibrosis, the authors suggest.  However, this is at odds with results from a recent UK study, which showed that all types of coffee (including decaffeinated) were protective against chronic liver disease.²

References

1. Niezen S, et al “Coffee consumption is associated with lower liver stiffness: A nationally representative study” Clin Gastroenterol Hepatol 2021; DOI: 10.1016/j.cgh.2021.09.042.
2. Kennedy, O.J., Fallowfield, J.A., Poole, R. et al.All coffee types decrease the risk of adverse clinical outcomes in chronic liver disease: a UK Biobank study. BMC Public Health 21, 970 (2021). https://doi.org/10.1186/s12889-021-10991-7

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In mouse models of human disease, immunotoxins targeting the protein mesothelin prevent liver cells from producing collagen, a precursor to fibrosis and cirrhosis. Effectively, this represents the use of an antibody-drug conjugate to target a feature of diseased tissue, an approach that is already in use in the management of solid tumours.

Chronic alcohol abuse and hepatitis can injure the liver and lead to fibrosis, the build-up of collagen and scar tissue. As a potential approach to treating liver fibrosis, University of California San Diego School of Medicine researchers and their collaborators are looking for ways to stop liver cells from producing collagen.

“So we thought…what if we take immunotoxins and try to get them to kill collagen-producing cells in the liver,” said team lead Tatiana Kisseleva, MD, PhD, associate professor of surgery at UC San Diego School of Medicine. “If these antibodies carrying toxic molecules can find and bind the cells, the cells will eat up the ‘gift’ and die.”

In a study published July 12, 2021 in Proceedings of the National Academy of Sciences, Kisseleva and collaborators provide the first evidence that liver fibrosis might be treatable with immunotoxins designed to bind a protein called mesothelin. Mesothelin is rarely found in the healthy human body. Only cancer cells and collagen-producing liver cells, known as portal fibroblasts, make the protein.

Kisseleva teamed up with co-author Ira Pastan, MD, at the National Cancer Institute, part of the National Institutes of Health (NIH). Pastan is co-discoverer of mesothelin and an expert on using immunotoxins to target the protein on cancer cells. He leads several clinical trials testing the approach to treat patients with ovarian cancer, mesothelioma and pancreatic cancer.

To test Pastan’s immunotoxins in the context of liver fibrosis, Kisseleva’s team first needed a model. Since the immunotoxins specifically recognize human mesothelin, a traditional mouse model of liver fibrosis wouldn’t work. Instead, they transplanted human liver cells isolated from patients to mice and treated them with the anti-mesothelin immunotoxin.

Compared to untreated mice, 60 to 100 percent of human mesothelin-producing cells were killed by the immunotoxins, which also reduced collagen deposition.

Treatment for liver fibrosis is currently very limited. According to the NIH, weight loss is currently the only known method for reducing liver fibrosis associated with non-alcoholic fatty liver disease. Alcoholic liver disease is most commonly treated with corticosteroids, but they are not highly effective. Early liver transplantation is the only proven cure, but it is offered only at select medical centres to a limited number of patients.

“What we want to know now is, can this same strategy be applied to other organs?” Kisseleva said. “Surprisingly enough, the same cells are responsible for fibrosis in the lung and kidneys. This is especially exciting because we already know from Dr. Pastan’s cancer clinical trials that anti-mesothelin immunotoxins are safe in humans, potentially speeding up their application in other areas.”

Reference

Nishio T. et al.  Immunotherapy-based targeting of MSLN⁺ activated portal fibroblasts is a strategy for treatment of cholestatic liver fibrosis. PNAS July 20, 2021 118 (29) e2101270118; https://doi.org/10.1073/pnas.2101270118

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Testosterone therapy may help obese men with functional hypogonadism and type-2 diabetes reduce the prevalence of non-alcoholic fatty liver disease (NAFLD), according to a study being presented at the 23^rd European Congress of Endocrinology (e-ECE 2021), (http://www.ece2021.org). The two-year study found that therapy with testosterone undecanoate normalised testosterone levels, reduced NAFLD, and suppressed the symptoms of hypogonadism in men living with these conditions.

NAFLD is emerging as a public health issue worldwide. It is estimated that prevalent cases will increase 21% by 2030, from 83.1 million to 100.9 million. NAFLD is more commonly found in people with type-2 diabetes, and is linked to obesity, insulin resistance and atherogenic dyslipidemia. NAFLD refers to excess fat accumulation in the liver, in the absence of excessive alcohol consumption. Alcohol consumption of less than 30 g (3.75 units) per day for men is used as the cut-off to diagnose NAFLD. As an increasing global health issue, this study and its findings may be a promising area for further research.

Dr Kristina Groti Antonic and her team from the University of Ljubljana, Slovenia, carried out a large study on the effects of testosterone therapy on glycemic control, metabolic parameters, vascular function and morphology in obese men with hypogonadism and type-2 diabetes mellitus. They presented a part of this study at e-ECE 2021 in which they evaluated the effects of testosterone therapy on morphology and grade of NAFLD in this population. The two-year clinical trial saw 55 males with functional hypogonadism and type-2 diabetes participate. The first year focused on a double blind, placebo-controlled study and the following year was used for follow-up.

During the study, the participants were randomised into two groups. The first group received testosterone undecanoate during both years of the study, while the second group received a placebo in the first year and testosterone therapy in the second year. A range of tests including testosterone levels, prostate specific antigen and routine blood tests were assessed at the beginning of the trial, 12 and 24 months. Liver ultrasounds for NAFLD grade assessments were performed at the beginning and after two years, which showed an improvement in NAFLD grades after two years of the trial.

Dr Kristina Groti Antonic shared that, “improvement of NAFLD grade was a result of improved insulin resistance, reduction in body mass index and body weight, along with changes in body composition. As we know, testosterone increases lean body mass at the expense of fat mass, either alone or in combination with behavioral and lifestyle modifications. Testosterone with its anti-inflammatory effects also reduced chronic inflammatory state in the liver. Our study shows that testosterone therapy could be used as a suitable therapy for obese men living with non-alcoholic fatty liver disease, and therefore the findings can be used to tackle this growing pandemic.”

This knowledge could help obese men living with functional hypogonadism and type-2 diabetes experience normalised testosterone levels and reduced prevalence of non-alcoholic fatty liver disease.

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