May 2025 • PharmaTimes Magazine • 9
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Leqembi approved as first treatment to slow early Alzheimer’s
The European Commission has granted marketing authorisation for Leqembi (lecanemab), making it the first therapy in the EU to slow the progression of early Alzheimer’s disease.
Lecanemab is indicated for adults with mild cognitive impairment or mild dementia due to Alzheimer’s who are apolipoprotein E ε4 non-carriers or heterozygotes with confirmed amyloid pathology.
The approval is based on phase 3 data from the Clarity AD trial, which demonstrated that lecanemab slowed disease progression compared with placebo over 18 months.
Gary Hendler, regional chairman and CEO at Eisai EMEA, said: “Today’s decision makes lecanemab the first treatment option in the European Union that can slow the progression of early Alzheimer’s disease and is a key step to making the medicine available to eligible patients.”
The decision applies to all 27 EU member states, as well as Iceland, Liechtenstein and Norway. Eisai will work with reimbursement authorities to ensure timely access.
The drug targets amyloid-beta protofibrils, a toxic form of amyloid that accumulates in the brain and contributes to cognitive decline.
Nick Burgin, president and COO at Eisai EMEA, added: “Achieving optimal outcomes for people treated with the medicine is of paramount importance.”
Biogen’s president for Europe, Wolfram Schmidt, called the approval a milestone in tackling Alzheimer’s.
Daratumumab established as standard of care for multiple myeloma
New data from Janssen-Cilag International NV suggest that subcutaneous DARZALEX (daratumumab) quadruplet therapy could offer a longer progression-free survival for patients with newly diagnosed multiple myeloma. Findings were presented at the 6th European Myeloma Network meeting in Athens.
Analysis based on the PERSEUS and CEPHEUS trials showed significant improvements in survival projections. Patients eligible for transplant treated with daratumumab-VRd had a median progression-free survival estimate of 17.1 years, compared to 7.3 years for those receiving VRd without daratumumab.
Pieter Sonneveld, Head of Hematology at Erasmus University Medical Center, said: “The PFS projections presented indicate that people with newly diagnosed multiple myeloma who are eligible for transplant and treated with the PERSEUS regimen may live more than 17 years without their disease progressing.”
The PERSEUS trial included transplant eligible patients with a median age of 60, while the CEPHEUS trial studied both eligible and ineligible patients with a median age of 70.
In PERSEUS, daratumumab-VRd with maintenance therapy reduced the risk of progression or death by 58 percent. In CEPHEUS, daratumumab-VRd reduced this risk by 43 percent.
Long-term modelling is increasingly used to inform economic and clinical decisions when median progression-free survival has not yet been reached. In the CEPHEUS trial, patients ineligible for transplant saw estimates of 8.3 years for daratumumab-VRd compared to 4.4 years for VRd.
HOT & NOT
Scientists from Juntendo University and The University of Tokyo have created an adeno-associated virus (AAV)-based genome editing approach to treat genetic hearing loss caused by the GJB2 R75W mutation. Their findings demonstrate the potential of this innovative therapy.
Hearing loss, when caused by the GJB2 gene mutation, results from fragmented gap junction plaques affecting auditory function.
While recessive mutations can be treated via gene replacement, dominant-negative mutations like R75W. require genome editing to restore the function of the wild-type protein.
The MHRA has approved the prostate cancer imaging agent trofolastat (RoTecPSMA). The regulator’s decision makes trofolastat the first prostate-specific membrane antigen (PSMA)-targeting product approved alongside the radioactive tracer technetium-99m to detect cancerous lesions in men with prostate cancer.
Approximately 55,100 new cases of prostate cancer are diagnosed every year in the UK, and diagnostic imaging plays a key role in the detection and management of the disease.
Nouscom has announced full safety and immunogenicity results from its phase 1b/2 trial of NOUS-209, an off-the-shelf immunotherapy for Lynch syndrome (LS). These findings were shared in an oral presentation at the American Academy of Cancer Research Annual Meeting in April.
The trial, which enrolled 45 participants with LS, assessed NOUS-209 as a potential cancer interception strategy. Results confirmed the therapy’s safety, with no serious treatment-related adverse events.
Janssen-Cilag has announced results from the phase 3 MARIPOSA study, demonstrating a significant overall survival benefit for patients with EGFR-mutated advanced non-small cell lung cancer.
The study compared Rybrevant (amivantamab) plus Lazcluze (lazertinib) to osimertinib as a first-line treatment.
The data, presented at the 2025 European Lung Cancer Congress, showed that the amivantamab plus lazertinib combination significantly extended overall survival compared to osimertinib.
Responding to the Care Quality Commission’s survey of community mental health users Rebecca Gray, mental health director at the NHS Confederation, said:
“This new survey is further worrying evidence of the delays people are facing trying to access vital mental health care, with many of these people waiting in debilitating ill health. As the CQC’s findings show, the longer people wait the more likely they were to report their conditions deteriorating.”
Responding to the latest British Social Attitudes survey, which shows public satisfaction with the NHS is at its record lowest, Dr Layla McCay, policy director at the NHS Confederation, said:
“While these findings will be a blow to those working in the NHS, unfortunately they are of little surprise given the survey was conducted at a time when the new government was communicating how ‘broken’ the NHS was and when waiting lists were so high.”
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