Pharmaceutical Market Europe • February 2026 • 8
NEWS
GSK’s Arexvy RSV vaccine receives expanded EC approval for use in adults
GlaxoSmithKline (GSK) has announced that Arexvy, its respiratory syncytial virus (RSV) vaccine, has received expanded approval from the European Commission (EC) for use in adults aged 18 and over.
Arexvy was previously approved for use in adults aged 60 and older, as well as adults aged 50 to 59 who presented an increased risk for RSV. It was the first RSV vaccine to receive authorisation in the European Economic Area for the prevention of lower respiratory tract disease (LRTD) caused by RSV.
RSV is a virus that impacts the lungs and breathing passages. It is contagious and affects around 64 million people around the world annually. Chronic conditions, advanced age or immunocompromised status can increase the risk of getting RSV. Additionally, RSV can make many chronic conditions worse, including chronic obstructive pulmonary disease (COPD), asthma and chronic heart failure. Serious cases of RSV can cause pneumonia, hospitalisation and death.
Approximately 158,000 adults are hospitalised for RSV infections annually in the EU. Adults hospitalised for RSV run a higher risk of severe complications and fatality than children.
EMA gives Rezurock positive CHMP opinion for chronic graft-versus-host disease
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has given Sanofi’s Rezurock (belumosudil) a positive opinion to treat adults and adolescents weighing over 40kg with chronic graft-versus-host disease (GVHD).
GVHD is a complication that can follow a stem cell transplant. It happens when donor cells attack the host’s cells and is characterised by inflammation and fibrosis, which can cause tissue and organ damage.
Up to half of allogeneic haematopoietic stem cell transplant patients develop chronic GVHD, and it is one of the leading causes of morbidity and late non-relapse mortality following a stem cell transplant. GVHD can seriously impact patients’ quality of life and places strain on healthcare systems.
The positive opinion is based on data from multiple studies, as well as real-world evidence regarding Rezurock. The phase 2 ROCKstar study showed that Rezurock offered durable response to GVHD patients who had already undergone two or more lines of systemic therapy.
The study also found that Rezurock was well tolerated. Sanofi also plans to conduct a confirmatory study to support the CHMP’s positive opinion.
AstraZeneca’s Imfinzi regimen receives positive CHMP opinion for early gastric and gastroesophageal cancer
AstraZeneca’s Imfinzi (durvalumab), in combination with standard of care FLOT chemotherapy (fluorouracil, leucovorin, oxaliplatin and docetaxel), has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for adults with resectable, early-stage and locally advanced gastric and gastroesophageal junction (GEJ) cancers.
The By 2030, around 62,000 patients across these regions are expected to be newly diagnosed with early-stage and locally advanced gastric or GEJ cancer.
The CHMP’s positive opinion is based on results from the phase 3 MATTERHORN trial. The trial showed that the Imfinzi-FLOT regimen reduced risk of death by 22% compared to chemotherapy alone. Around 69% of Imfinzi-FLOT-treated patients were alive at three years, compared to 62% of patients in the comparator arm of the study.
Gastric cancer is the fifth highest cause of cancer deaths worldwide, and almost a million people are diagnosed with it each year. There were around 43,000 patients treated for early-stage and locally advanced gastric or GEJ cancer in the US, EU and Japan in 2024.
Pharmaceutical Market Europe (PME)
Pharmaceutical industry news, articles, jobs, reports, advice and services