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.

The post Nine new treatments approved by NICE in active June cycle, with two appraisals terminated appeared first on Pharmacy Update Online.

Oncology and dermatology feature prominently in this cycle, with notable recommendations for novel antibody-drug conjugates, a new JAK inhibitor indication, and an innovative combination approach in multiple myeloma. The cycle also includes three vaccine recommendations addressing chikungunya, meningococcal disease, influenza, and orthopoxvirus infections.

Oncology

Datroway recommended for triple-negative breast cancer

Datopotamab deruxtecan (Datroway), an antibody-drug conjugate developed by Daiichi Sankyo and AstraZeneca, has received a positive CHMP recommendation for triple-negative breast cancer (TNBC). TNBC remains one of the most challenging breast cancer subtypes to treat, given its lack of hormone receptor and HER2 expression. Datroway targets TROP2, a protein overexpressed in many epithelial tumours, and delivers a cytotoxic payload selectively to cancer cells, offering a more targeted approach than conventional chemotherapy.

Tecvayli and Darzalex Faspro combination recommended for multiple myeloma

Johnson & Johnson has received a CHMP recommendation for the combination of teclistamab and daratumumab (Tecvayli and Darzalex Faspro) for multiple myeloma. Teclistamab is a bispecific T-cell engager targeting BCMA and CD3, while daratumumab is a well-established anti-CD38 monoclonal antibody. Combining the two mechanisms in a chemotherapy-free regimen represents a significant advance in the treatment of relapsed or refractory multiple myeloma, a condition that typically requires repeated lines of therapy over time.

Jaypirca recommended for chronic lymphocytic leukaemia

Pirtobrutinib (Jaypirca), a non-covalent BTK inhibitor developed by Loxo Oncology at Lilly and Eli Lilly, has been recommended for chronic lymphocytic leukaemia and small lymphocytic lymphoma (CLL/SLL). Unlike covalent BTK inhibitors such as ibrutinib, pirtobrutinib is designed to remain active in patients who have developed resistance mutations, offering a treatment option for a population with limited alternatives following prior BTK inhibitor therapy.

Denosumab biosimilar recommended for bone complications in cancer

Denosumab Ascend, a biosimilar of denosumab developed by Ascend GmbH, has received a CHMP recommendation for the prevention of skeletal-related events in patients with bone metastases and for giant cell tumour of bone. The availability of a biosimilar version of this widely used bone-targeted agent is expected to improve patient access and reduce costs for health systems across the EU.

Pegfilgrastim biosimilar recommended for neutropenia

Nylaspeg, a biosimilar of pegfilgrastim submitted by Qilu Pharmaceuticals, has received a positive recommendation for chemotherapy-induced neutropenia. Pegfilgrastim is routinely used to stimulate white blood cell production and reduce the risk of febrile neutropenia in cancer patients receiving myelosuppressive chemotherapy. The biosimilar recommendation supports continued access to this supportive care treatment at competitive cost.

Dermatology & Immunology

Rinvoq recommended for vitiligo and alopecia areata

AbbVie’s upadacitinib (Rinvoq), a selective JAK1 inhibitor, has received two separate CHMP recommendations expanding its indications into dermatology: one for vitiligo and one for alopecia areata. Vitiligo is a chronic autoimmune condition causing depigmentation of the skin, while alopecia areata results in patchy or total hair loss driven by immune-mediated attack on hair follicles. Both conditions have historically lacked effective systemic treatments, and these recommendations follow growing clinical evidence supporting JAK inhibition as a mechanism of action in autoimmune skin diseases. Rinvoq is already approved for several inflammatory conditions including rheumatoid arthritis, psoriatic arthritis, and atopic dermatitis.

Opzelura recommended for atopic dermatitis

Ruxolitinib cream (Opzelura), developed by Incyte Corporation and Maruho, has received a CHMP recommendation for atopic dermatitis (eczema). Opzelura is a topical JAK1/JAK2 inhibitor that provides targeted anti-inflammatory activity at the site of application, offering an alternative to topical corticosteroids for patients with mild to moderate disease. The recommendation addresses a highly prevalent condition that places significant quality of life burden on patients, particularly those with disease affecting visible areas of skin.

Neurology & Paediatrics

Daybue recommended for Rett syndrome

Trofinetide (Daybue), developed by Acadia Pharmaceuticals, has received a CHMP recommendation for Rett syndrome, a rare and severe neurodevelopmental disorder caused by mutations in the MECP2 gene, which predominantly affects girls. The condition leads to progressive loss of motor and communication skills and has no approved disease-modifying treatments in the EU. Daybue is a synthetic analogue of the naturally occurring tripeptide GPE (glycine-proline-glutamate) and represents the first pharmacological treatment specifically developed for this condition to receive a positive EU recommendation.

Crexont recommended for Parkinson’s disease

A prolonged-release combination of carbidopa and levodopa (Crexont), submitted by Amneal Pharmaceuticals and Zambon, has been recommended for Parkinson’s disease. Levodopa remains the cornerstone of Parkinson’s pharmacotherapy, but standard formulations are associated with motor fluctuations and wearing-off effects as the disease progresses. The extended-release formulation aims to provide more consistent plasma drug levels throughout the day, potentially reducing the frequency and severity of motor complications in patients with advanced disease.

Stelara recommended for paediatric ulcerative colitis

Ustekinumab (Stelara), developed by Johnson & Johnson, has received a CHMP recommendation for paediatric ulcerative colitis. Ustekinumab is an interleukin-12 and interleukin-23 inhibitor already established in adult inflammatory bowel disease and psoriasis. This paediatric recommendation addresses a significant unmet need in younger patients with moderate to severe ulcerative colitis who have an inadequate response to conventional therapy.

Infectious Diseases & Vaccines

Ixchiq recommended for chikungunya fever

Ixchiq, a live-attenuated chikungunya vaccine developed by Valneva SE and Instituto Butantan, has received a positive CHMP recommendation. Chikungunya is a mosquito-borne viral illness characterised by fever and severe joint pain, with outbreaks increasingly reported in southern Europe due to the northward spread of the Aedes albopictus mosquito. The approval of a preventive vaccine represents an important public health tool as the geographical range of the disease continues to expand.

MenQuadfi recommended for meningococcal disease

MenQuadfi, a conjugate vaccine targeting meningococcal serogroups A, C, W, and Y, developed by Sanofi, has received a CHMP recommendation. Meningococcal disease can cause life-threatening bacterial meningitis and septicaemia, particularly in infants, young children, and adolescents. The conjugate formulation is designed to produce a robust and long-lasting immune response and is suitable for use in paediatric populations.

Imvanex recommended for monkeypox and orthopoxvirus infections

Bavarian Nordic’s Imvanex, a modified vaccinia Ankara-based vaccine, has received a CHMP recommendation for protection against monkeypox (mpox) and other orthopoxvirus infections. Imvanex was already authorised for smallpox prevention in the EU and was used extensively during the 2022 mpox outbreak. This recommendation formalises its indication for mpox and broader orthopoxvirus prophylaxis, reflecting the continued public health relevance of the product.

Aujemflu recommended for influenza

Aujemflu, an adjuvanted trivalent influenza vaccine developed by Seqirus/CSL, has received a CHMP recommendation for the prevention of influenza. The adjuvanted formulation is designed to enhance immunogenicity, particularly in older adults and immunocompromised populations where vaccine responses may be suboptimal. The recommendation adds to the existing portfolio of seasonal influenza vaccines available to EU member states.

Symtuza and Prezcobix recommended for HIV

Two HIV antiretroviral regimens have received CHMP recommendations. Symtuza — a single-tablet combination of darunavir, emtricitabine, cobicistat, and tenofovir alafenamide (TAF), developed by Johnson & Johnson and Gilead Sciences — offers a complete one-tablet-once-daily regimen for HIV-1 infection. Separately, Prezcobix — a combination of darunavir and cobicistat developed by Janssen Therapeutics — provides a boosted protease inhibitor backbone for use in combination with other antiretrovirals. Both recommendations likely reflect updated indications or label revisions for these established regimens.

Cardiovascular & Diabetes

Leqvio recommended for hypercholesterolaemia

Inclisiran (Leqvio), a small interfering RNA (siRNA) therapy developed by Novartis, has received a CHMP recommendation for hypercholesterolaemia. Inclisiran works by inhibiting the production of PCSK9, a protein that reduces the liver’s ability to clear LDL cholesterol from the blood. Administered just twice yearly by subcutaneous injection, inclisiran offers a highly differentiated dosing schedule compared with daily oral statins or monthly PCSK9 inhibitor antibodies, which may improve adherence in patients requiring long-term lipid-lowering therapy.

Onswik recommended for type 2 diabetes

Insulin efsitora alfa (Onswik), a once-weekly basal insulin analogue developed by Eli Lilly, has received a positive CHMP recommendation for type 2 diabetes. The treatment represents a significant step forward in insulin therapy, offering a weekly injection as an alternative to the daily or twice-daily basal insulin regimens that many patients find burdensome. A reduced injection frequency is expected to support better adherence and patient quality of life, particularly in the early stages of insulin initiation.

All nineteen decisions listed carry CHMP Recommended status. CHMP recommendations are subject to final marketing authorisation by the European Commission. This article is based on data from the European Medicines Agency CHMP opinion cycle.

The post Nineteen further treatments recommended as CHMP continues active approvals cycle appeared first on Pharmacy Update Online.

• Receive an email
• click on webinar registration
• confirm that you are a health care professional
• complete 5-7 questions to register
• Put the date and time in your diary.
• On the day of the webinar open confirmation email and listen for 30-45 mins.

• Receive an email that has a video already embedded in the content that contains 5-6 carefully structured questions being answered by a key opinion leader.

The post Have Pharma gone Webinar crazy!? appeared first on Pharmacy Update Online.