Three treatments approved by NICE in September, with one negative decision
The National Institute for Health and Care Excellence (NICE) has issued four Technology Appraisal decisions in September 2026, comprising three positive first recommendations and one negative decision. Decisions were issued between 9 and 23 September 2026 and span oncology, neurology, haematological cancer, and dermatology. Though a smaller cycle than some preceding months, the decisions include a notable first approved treatment for neurofibromatosis type 1-associated plexiform neurofibromas in children and adults, and a significant combination regimen in endometrial cancer that may reshape standard-of-care treatment in that setting.
The single negative decision — for nemolizumab in prurigo nodularis — reflects the ongoing challenge of demonstrating cost-effectiveness for treatments targeting rare and highly burdensome skin conditions, despite clear clinical evidence of benefit.
Positive Recommendations
Gomekli recommended for neurofibromatosis type 1 — a first approved treatment
Mirdametinib (Gomekli), developed by Springworks Therapeutics and MerckKGaA, received a positive NICE recommendation on 16 September 2026 for neurofibromatosis type 1 (NF1)-associated plexiform neurofibromas in adults and children. NF1 is a rare inherited genetic condition caused by mutations in the NF1 tumour suppressor gene, leading to uncontrolled cell growth in nerve tissue. Plexiform neurofibromas are benign but often disfiguring and functionally impairing tumours that can cause chronic pain, neurological deficits, and airway compression depending on their location, and have historically been managed primarily through surgery. Mirdametinib is a selective MEK1/2 inhibitor that targets the RAS/MAPK signalling pathway activated by loss of neurofibromin, the protein encoded by the NF1 gene. The recommendation represents a landmark moment for the NF1 community, providing the first approved oral systemic therapy for this manifestation of the condition on the NHS.
Imfinzi combination recommended for endometrial cancer
Durvalumab (Imfinzi) in combination with carboplatin and paclitaxel chemotherapy, with or without olaparib (Lynparza), was recommended by NICE on 9 September 2026 for advanced or recurrent endometrial cancer. Submitted by AstraZeneca, this regimen reflects the emerging stratified approach to endometrial cancer treatment, in which the addition of a PARP inhibitor such as olaparib is directed at patients whose tumours show homologous recombination deficiency or specific molecular features. Durvalumab is a PD-L1 checkpoint inhibitor that augments the anti-tumour immune response alongside the cytotoxic effects of platinum-based chemotherapy. The recommendation positions this combination as a new standard-of-care option in a disease where systemic treatment outcomes have historically been poor in the relapsed or advanced setting.
Imbruvica plus R-CHOP recommended for mantle cell lymphoma
Ibrutinib (Imbruvica) in combination with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisolone (R-CHOP), submitted by AbbVie and Janssen Biotech, received a positive NICE recommendation on 23 September 2026 for previously untreated mantle cell lymphoma (MCL) in adults who are eligible for intensive chemotherapy. MCL is an aggressive B-cell non-Hodgkin lymphoma with a tendency to relapse and a historically poor long-term prognosis despite initial responsiveness to treatment. Adding ibrutinib — a Bruton’s tyrosine kinase inhibitor — to the established R-CHOP immunochemotherapy backbone targets both the B-cell receptor signalling pathway and the tumour’s microenvironment. Clinical evidence has demonstrated improved progression-free survival with the ibrutinib-containing regimen in younger, transplant-eligible patients, and the recommendation opens this intensified approach to eligible NHS patients for the first time.
Negative Decision
Mitchga not recommended for prurigo nodularis
NICE issued a negative recommendation on 9 September 2026 for nemolizumab (Mitchga), an anti-interleukin-31 receptor A monoclonal antibody developed by Galderma, Chugai/Roche, and Maruho, for the treatment of prurigo nodularis. Prurigo nodularis is a chronic and severely distressing dermatological condition characterised by intensely itchy nodules distributed across the body, driven by a neuroimmune inflammatory mechanism in which IL-31 plays a central role. The condition causes profound impairment of quality of life and has very limited licensed treatment options, making the negative decision a significant disappointment for affected patients.
Nemolizumab has demonstrated clinically meaningful reductions in itch intensity and lesion burden in pivotal trials, and is approved in other markets including the United States and Japan. NICE’s negative determination is likely to reflect concerns regarding cost-effectiveness at the submitted price rather than a lack of clinical efficacy. The decision may be subject to further negotiation or resubmission, and patients and clinicians will be watching closely for any appeal or managed access arrangement that could bring this treatment to NHS patients in the future.
Decisions referenced carry NICE Positive 1 or NICE Negative status, issued between 9–23 September 2026. This article is based on data from the NICE Technology Appraisal Programme for England and Wales.
