Nineteen treatments recommended as CHMP delivers broad September approvals cycle
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued nineteen positive recommendations between 17 and 21 September 2026, spanning oncology, rheumatology, dermatology, neurology, haematology, ophthalmology, gastroenterology, and infectious disease. The September cycle is one of the most wide-ranging of the year, with multiple myeloma, ovarian cancer, and spondyloarthritis each featuring more than once, alongside a notable biosimilar recommendation for omalizumab that will broaden patient access to a well-established biologic therapy.
The cycle also includes two significant first-in-class or novel-mechanism approvals: a subcutaneous formulation of ocrelizumab for multiple sclerosis offering a faster administration option compared with the established intravenous infusion, and gefurulimab, a new complement inhibitor for myasthenia gravis. Rheumatology features prominently, with filgotinib receiving two separate recommendations for related but distinct forms of spondyloarthritis in the same cycle.
Oncology
Enhertu recommended for HER2-positive breast cancer
Fam-trastuzumab deruxtecan (Enhertu), developed by Daiichi Sankyo and AstraZeneca, received a CHMP recommendation on 18 September 2026 for HER2-positive breast cancer. Enhertu is a HER2-directed antibody-drug conjugate that has transformed the treatment landscape across multiple HER2-expressing tumour types. This recommendation reflects the continued expansion of its approved indications in breast cancer, building on earlier approvals for HER2-low and HER2-ultralow disease. The drug’s high drug-to-antibody ratio and membrane-permeable payload contribute to a bystander effect that may benefit tumours with heterogeneous HER2 expression.
Keytruda and Padcev combination recommended for muscle-invasive bladder cancer
Pembrolizumab (Keytruda) in combination with enfortumab vedotin (Padcev), submitted by Merck, Astellas, and Pfizer, received a CHMP recommendation on 18 September 2026 for muscle-invasive bladder cancer. This combination pairs a PD-1 checkpoint inhibitor with a Nectin-4-directed antibody-drug conjugate, targeting both immune evasion and tumour cell proliferation. The recommendation follows strong clinical evidence supporting this chemotherapy-free regimen as a front-line treatment option, extending its reach in urothelial cancer beyond the metastatic setting in which it was first established.
Ensacove recommended for ALK-positive non-small cell lung cancer
Ensartinib (Ensacove), an ALK inhibitor developed by Xcovery and Betta Pharmaceuticals, received a CHMP recommendation on 17 September 2026 for ALK-positive non-small cell lung cancer (NSCLC). ALK rearrangements are present in approximately three to five per cent of NSCLC cases and define a molecularly distinct subgroup that is highly sensitive to ALK-directed therapy. Ensartinib is a next-generation ALK inhibitor with activity against several resistance mutations that limit the efficacy of earlier agents in this class, offering an additional treatment option in a landscape already served by crizotinib, alectinib, brigatinib, and lorlatinib.
Tecvayli recommended for multiple myeloma
Teclistamab (Tecvayli), a BCMA/CD3 bispecific T-cell engager developed by Janssen Biotech, received a CHMP recommendation on 17 September 2026 for relapsed or refractory multiple myeloma. Tecvayli redirects cytotoxic T cells to BCMA-expressing myeloma cells, offering a chemotherapy-free immunological approach for patients who have exhausted prior lines of therapy. The recommendation adds to an increasingly complex therapeutic landscape in myeloma, which now includes proteasome inhibitors, immunomodulatory drugs, anti-CD38 monoclonal antibodies, BCMA-directed ADCs, and CAR-T therapies.
Pepaxto recommended for multiple myeloma
Melflufen in combination with dexamethasone (Pepaxto), developed by Oncopeptides, received a CHMP recommendation on 17 September 2026 for relapsed or refractory multiple myeloma. Melflufen is a peptide-drug conjugate that is selectively taken up by myeloma cells and cleaved intracellularly to release a cytotoxic alkylating agent. The agent targets a patient population with heavily pretreated, late-line disease, and its approval provides an additional option where treatment choices are often limited by prior exposure and resistance to established drug classes.
Lifyorli and Abraxane combination recommended for ovarian cancer
Relacorilant in combination with nab-paclitaxel (Lifyorli and Abraxane), submitted by Corcept Therapeutics, received a CHMP recommendation on 18 September 2026 for platinum-resistant ovarian cancer. Relacorilant is a selective glucocorticoid receptor modulator that blocks the pro-survival signalling that glucocorticoids can induce in tumour cells, potentially overcoming a mechanism of resistance to taxane-based chemotherapy. The combination represents a novel approach to a cancer type in which platinum resistance is a significant clinical challenge, and where effective second-line options remain limited.
Sepalna recommended for ovarian cancer
Senaparib (Sepalna), a PARP inhibitor developed by IMPACT Therapeutics and partnered with SFL Pharmaceuticals, received a CHMP recommendation on 17 September 2026 for ovarian cancer. PARP inhibitors exploit deficiencies in DNA repair pathways — particularly homologous recombination deficiency associated with BRCA mutations — to selectively kill cancer cells. Sepalna adds to an established class that includes olaparib, niraparib, and rucaparib, and its approval provides a further PARP inhibitor option for eligible patients across the ovarian cancer treatment continuum.
Rheumatology & Immunology
Jyseleca recommended for ankylosing spondylitis and axial spondyloarthritis
Filgotinib (Jyseleca), a selective JAK1 inhibitor developed by Eisai and Alfasigma, received two separate CHMP recommendations on 17 September 2026: one for ankylosing spondylitis (AS) and a second for non-radiographic axial spondyloarthritis (nr-axSpA), together covering the full spectrum of axial spondyloarthritis. AS is the radiographically confirmed form of axial SpA characterised by structural changes to the sacroiliac joints and spine, while nr-axSpA describes the earlier or less structurally severe presentation. The dual recommendation reflects the breadth of filgotinib’s clinical evidence across these related conditions, extending its established use in rheumatoid arthritis and ulcerative colitis into a further inflammatory rheumatological indication.
Cosentyx recommended for polymyalgia rheumatica
Secukinumab (Cosentyx), an anti-interleukin-17A monoclonal antibody developed by Novartis, received a CHMP recommendation on 18 September 2026 for polymyalgia rheumatica (PMR). PMR is a common inflammatory condition in older adults causing pain and stiffness in the shoulders, neck, and hips, and is currently managed primarily with long-term corticosteroid therapy, which carries significant cumulative side effects. Secukinumab is already approved for multiple immune-mediated inflammatory conditions including psoriasis, ankylosing spondylitis, and psoriatic arthritis; this recommendation in PMR represents a meaningful addition for a patient group in which steroid-sparing treatments are greatly needed.
Dermatology
Anzupgo recommended for atopic dermatitis
Delgocitinib (Anzupgo), a pan-JAK inhibitor developed by Japan Tobacco and Leo Pharma in a topical formulation, received a CHMP recommendation on 17 September 2026 for moderate to severe atopic dermatitis in adults. Topical JAK inhibitors represent an emerging class in atopic dermatitis that offer targeted anti-inflammatory activity at the site of application while minimising systemic exposure. Delgocitinib inhibits all four JAK isoforms and has demonstrated efficacy in patients with disease inadequately controlled by topical corticosteroids, providing a steroid-sparing alternative for chronic or difficult-to-manage disease.
Povofortay recommended for hidradenitis suppurativa
Povorcitinib (Povofortay), a selective JAK1 inhibitor developed by Incyte Corporation, received a CHMP recommendation on 17 September 2026 for hidradenitis suppurativa (HS), a chronic inflammatory skin condition characterised by recurrent painful nodules, abscesses, and scarring in the axillae, groin, and other intertriginous areas. HS is frequently debilitating and has historically been difficult to treat, with biologics targeting TNF-alpha and IL-17 offering only partial responses in many patients. Povorcitinib provides the first oral JAK inhibitor option in HS and may address patients who have an inadequate response to or cannot tolerate existing biologic therapies.
Neurology & Immunology
Ocrevus subcutaneous formulation recommended for multiple sclerosis
A subcutaneous formulation of ocrelizumab (Ocrevus SC), developed by Roche, Biogen, and Genentech, received a CHMP recommendation on 17 September 2026 for relapsing and primary progressive multiple sclerosis. Ocrelizumab is a CD20-directed B-cell depleting monoclonal antibody already widely used in its intravenous form, which requires administration by healthcare professionals in a clinical setting over several hours. The subcutaneous formulation offers a faster injection that may be suitable for home or self-administration in eligible patients, representing a meaningful advance in convenience and healthcare resource use without compromising efficacy.
Klygefa recommended for myasthenia gravis
Gefurulimab (Klygefa), a complement C2 inhibitor developed by Alexion Pharmaceuticals and AstraZeneca, received a CHMP recommendation on 18 September 2026 for generalised myasthenia gravis. Complement pathway inhibition is an established mechanism in myasthenia gravis, with anti-C5 agents already approved in this setting. Gefurulimab targets C2, an upstream component of both the classical and lectin pathways, offering a potentially broader complement blockade. The recommendation adds a further mechanistic option to a disease area that has seen rapid therapeutic development in recent years.
Haematology & Paediatrics
Frehemgo recommended for haemophilia A
Denecimig (Frehemgo), a novel bispecific antibody developed by Novo Nordisk, received a CHMP recommendation on 17 September 2026 for haemophilia A, including in paediatric patients. Denecimig mimics the cofactor function of factor VIII by bridging activated factor IX and factor X, enabling the coagulation cascade to proceed in the absence of endogenous factor VIII. The approach offers an alternative to factor replacement therapy that may be particularly valuable for patients with inhibitors — antibodies that neutralise infused factor VIII and render standard replacement therapy ineffective. The once-weekly subcutaneous administration route also offers a practical advantage over intravenous factor concentrate infusions.
Adcomfo biosimilar recommended for allergic asthma, urticaria, and nasal polyps
Adcomfo, a biosimilar of omalizumab developed by Alvotech and Advanz Pharma, received a CHMP recommendation on 17 September 2026 for allergic asthma, chronic spontaneous urticaria, and chronic rhinosinusitis with nasal polyps. Omalizumab is an anti-IgE monoclonal antibody that reduces the allergic inflammatory response and is already established across these three indications in its originator form (Xolair). As the first omalizumab biosimilar to receive a CHMP recommendation, Adcomfo is expected to increase competition in the market and improve patient access by reducing treatment costs across EU healthcare systems.
Ophthalmology
Susvimo implant recommended for age-related macular degeneration
The ranibizumab 100 mg/mL intravitreal implant (Susvimo), developed by Genentech/Roche and Novartis, received a CHMP recommendation on 21 September 2026 for neovascular (wet) age-related macular degeneration (AMD). Susvimo is a surgically implanted ocular device that delivers a continuous, sustained release of ranibizumab directly into the vitreous, avoiding the need for frequent intravitreal injections that characterise standard anti-VEGF therapy for wet AMD. The recommendation, which mirrors a decision also taken at the EU level this cycle, positions Susvimo as a long-term management option for patients with wet AMD who would benefit from a reduced injection burden.
Gastroenterology
Zeydovio recommended for short bowel syndrome
Glepaglutide (Zeydovio), a long-acting GLP-2 receptor agonist developed by Zealand Pharma, received a CHMP recommendation on 18 September 2026 for short bowel syndrome (SBS) in adults. SBS is a rare and debilitating condition resulting from the surgical removal or congenital absence of a significant portion of the small intestine, leaving patients dependent on parenteral nutrition for survival. GLP-2 receptor agonists promote intestinal adaptation by stimulating mucosal growth and improving absorptive capacity, with the goal of reducing or eliminating dependence on parenteral nutrition. Glepaglutide’s once-weekly dosing schedule, made possible by its extended half-life, offers a significant practical advantage over the twice-daily injections required with teduglutide, the existing approved GLP-2 analogue in this indication.
Infectious Diseases
VaxRabeo recommended for rabies prevention
VaxRabeo, an inactivated rabies vaccine developed by Sanofi Winthrop Industrie, received a CHMP recommendation on 17 September 2026 for the pre- and post-exposure prevention of rabies. Rabies remains a significant cause of mortality globally, particularly in parts of Asia and Africa, and EU travellers to endemic regions require access to reliable pre-exposure prophylaxis. The recommendation for VaxRabeo adds to the existing portfolio of approved rabies vaccines available within the EU and ensures continued supply of this important public health intervention.
All nineteen decisions listed carry CHMP Recommended status and were issued between 17–21 September 2026. 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.
