Nineteen new treatments recommended as CHMP issues major wave of EU approvals
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued nineteen positive recommendations across two days in May 2026, covering a broad spectrum of therapeutic areas including oncology, respiratory disease, endocrinology, and rare genetic disorders. The decisions, issued on 21 and 22 May 2026, represent one of the most substantial batches of EU approvals in recent months and will pave the way for marketing authorisation across European Union member states.
The recommendations span treatments for both common and rare conditions, with oncology accounting for the largest share. Several decisions involve combination regimens and expanded indications for established agents, reflecting the growing complexity of modern cancer treatment strategies.
ONCOLOGY
Trodelvy recommended for triple-negative breast cancer
Sacituzumab govitecan (Trodelvy), developed by Immunomedics and Gilead, received a positive CHMP recommendation on 22 May 2026 for the treatment of triple-negative breast cancer (TNBC). TNBC is an aggressive subtype that lacks the three receptors most commonly targeted in breast cancer therapy, making it particularly difficult to treat. Trodelvy is an antibody-drug conjugate that delivers a cytotoxic payload directly to tumour cells, offering a targeted approach in a setting where treatment options have historically been limited.
Enhertu recommended for HER2-positive solid tumours
Trastuzumab deruxtecan (Enhertu), a product of Daiichi Sankyo and AstraZeneca, was recommended on 22 May 2026 for HER2-positive solid tumours. The recommendation reflects an expanding understanding of HER2 as a targetable biomarker across multiple cancer types, not only in breast and gastric cancers where the drug is already established. This tumour-agnostic approach marks a significant shift in the treatment paradigm for patients with HER2-amplified cancers regardless of their primary site.
Braftovi Triplet recommended for colorectal cancer
The three-drug combination of encorafenib, binimetinib, and cetuximab — known as the Braftovi Triplet — received a CHMP recommendation on 21 May 2026 for BRAF V600E mutation-positive metastatic colorectal cancer. Developed by Array Biopharma/Pfizer and Pierre Fabre, the regimen targets BRAF, MEK, and EGFR simultaneously, aiming to overcome the adaptive resistance that limits the efficacy of doublet regimens in this setting.
Braftovi Doublet recommendation extended for colorectal cancer
Separately, the doublet combination of encorafenib and cetuximab (Braftovi Doublet) also received a CHMP recommendation on 21 May 2026, specifically for BRAF V600E mutation-positive colorectal cancer. Submitted by Pfizer, Ono Pharma, and Pierre Fabre, this recommendation may reflect an updated indication or an extension of the existing approval for patients who may not be suitable candidates for the full triplet regimen.
Etcamah recommended for HR-positive, HER2-negative breast cancer with ESR1 mutation
Camizestrant in combination with CDK4/6 inhibitors (palbociclib, ribociclib, or abemaciclib), branded as Etcamah and developed by AstraZeneca, was recommended on 22 May 2026 for hormone receptor-positive, HER2-negative breast cancer harbouring an ESR1 mutation. ESR1 mutations are a recognised driver of resistance to aromatase inhibitors, and this combination addresses a clinically important unmet need in patients whose disease has progressed on first-line endocrine therapy.
Epkinly triplet recommended for follicular lymphoma
The combination of epcoritamab, rituximab, and lenalidomide (Epkinly, Rituxan, and Revlimid) received a CHMP recommendation on 21 May 2026 for relapsed or refractory follicular lymphoma. Developed by AbbVie and Genmab, this regimen pairs a bispecific CD3/CD20-targeting antibody with two established agents, offering a chemotherapy-free option for patients with this indolent but often recurring B-cell malignancy.
Keytruda and Padcev recommended for muscle-invasive bladder cancer
Two closely related recommendations were issued on 22 May 2026 for muscle-invasive bladder cancer: one for intravenous pembrolizumab combined with enfortumab vedotin (Keytruda and Padcev), and a second for a subcutaneous formulation of pembrolizumab combined with enfortumab vedotin (Keytruda Qlex and Padcev). Both regimens are submitted by Merck, Astellas, and Pfizer. The inclusion of a subcutaneous option for pembrolizumab alongside the established intravenous formulation offers practical benefits in terms of administration convenience and healthcare resource use.
Iclusig recommended for chronic myelogenous leukaemia
Ponatinib (Iclusig), a third-generation BCR-ABL tyrosine kinase inhibitor developed by Ariad Pharma/Takeda and a consortium of regional partners, received a CHMP recommendation on 21 May 2026 for chronic myelogenous leukaemia (CML). Ponatinib is specifically designed to address the T315I mutation, a common mechanism of resistance to earlier-generation TKIs, and represents an important option for patients who have failed multiple prior therapies.
RESPIRATORY
Jascayd recommended for idiopathic pulmonary fibrosis and progressive pulmonary fibrosis
Nerandomilast (Jascayd), developed by Boehringer Ingelheim, received two separate CHMP recommendations on 22 May 2026: one for idiopathic pulmonary fibrosis (IPF) and a second for progressive pulmonary fibrosis (PPF). IPF is a chronic, irreversible lung condition with a poor prognosis and limited treatment options, while PPF describes a broader category of fibrotic lung diseases with a worsening trajectory. The dual recommendation reflects the breadth of the drug’s potential clinical utility and positions nerandomilast as a meaningful addition to the current standard of care.
Fasenra recommended for hypereosinophilic syndrome
Benralizumab (Fasenra), an anti-IL-5 receptor monoclonal antibody developed by AstraZeneca and Kyowa Kirin, was recommended on 21 May 2026 for hypereosinophilic syndrome (HES). HES is a rare disorder defined by persistently elevated blood eosinophil counts, which can cause organ damage if left untreated. Benralizumab is already established in severe eosinophilic asthma, and this recommendation represents a meaningful label extension into a related rare disease population.
ENDOCRINOLOGY & METABOLIC DISEASE
Wegovy oral recommended for obesity
Novo Nordisk received a CHMP recommendation on 21 May 2026 for a 25 mg oral once-daily formulation of semaglutide (Wegovy oral) for the treatment of obesity. The recommendation marks a significant development in the GLP-1 receptor agonist class, which has until now been dominated by injectable formulations. An oral option is expected to improve accessibility and patient acceptability, potentially broadening the eligible treatment population.
Ablymico recommended for obesity
A further obesity treatment, liraglutide hybrid (Ablymico), was recommended on 21 May 2026. Developed by Stada Medice Arzneimittel, Ablymico is a hybrid formulation of liraglutide. The recommendation adds to a growing portfolio of pharmacological obesity treatments now available in the EU, reflecting sustained regulatory and clinical interest in addressing the obesity epidemic.
Sogroya recommended for growth hormone deficiency
Somapacitan (Sogroya), a once-weekly growth hormone therapy developed by Novo Nordisk, received a CHMP recommendation on 21 May 2026 for growth hormone deficiency, including in paediatric patients. The once-weekly dosing schedule represents a notable advance over daily growth hormone injections, which have long been the standard of care and are a source of significant burden for patients and families.
RARE & GENETIC DISEASES
Palynziq recommended for phenylketonuria
Pegvaliase (Palynziq), developed by BioMarin, received a CHMP recommendation on 21 May 2026 for phenylketonuria (PKU), a rare inherited metabolic disorder caused by the inability to metabolise the amino acid phenylalanine. Elevated phenylalanine levels can cause severe neurological damage if untreated. Palynziq is an enzyme substitution therapy that degrades phenylalanine and offers a treatment option for patients who have not responded adequately to other therapies, including those who are not eligible for the established PKU treatment sapropterin.
Piqray recommended for PIK3CA-related overgrowth spectrum
Alpelisib (Piqray), developed by Novartis, was recommended on 22 May 2026 for PIK3CA-related overgrowth spectrum (PROS), a group of rare congenital conditions caused by mutations in the PIK3CA gene that result in localised or diffuse tissue overgrowth. This recommendation represents an expansion of alpelisib’s indication beyond its existing use in breast cancer, and constitutes one of the first targeted therapies for PROS, a condition that has historically been managed through surgery and supportive care.
HEPATOLOGY & CARDIOVASCULAR
Mavyret receives updated recommendation for hepatitis C
Glecaprevir and pibrentasvir (Mavyret), a pan-genotypic direct-acting antiviral combination developed by AbbVie, received a further CHMP recommendation on 22 May 2026 for hepatitis C. Mavyret is already widely used across Europe for the treatment of chronic hepatitis C infection and its re-entry in this recommendation cycle likely reflects an updated indication, a new patient population, or a label modification.
Colchicine hybrid recommended for atherothrombotic events
A hybrid formulation of colchicine, submitted by Agepha Pharma, received a CHMP recommendation on 21 May 2026 for the prevention of atherothrombotic events. Colchicine is a well-established anti-inflammatory agent, and its cardiovascular application is supported by recent evidence demonstrating a reduction in recurrent cardiovascular events in patients with coronary artery disease. This hybrid formulation approval extends the drug’s availability in a cardiovascular indication.
All nineteen decisions listed are CHMP Recommended status, issued on 21–22 May 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.
