EMA Recommends Five New Drugs, Including Lung Cancer Treatment

Published on: March 30, 2026

During its March 2026 meeting, the agency’s Committee for Medicinal Products for Human Use approved treatments for Bacillus Calmette-Guérin unresponsive non-muscle invasive bladder cancer, relapsed extensive-stage small cell lung cancer, activated phosphoinositide 3-kinase delta syndrome, and oedema of cardiac, renal, hepatic origin, and hypertension in children.

The European Medicines Agency (EMA) announced on March 27, 2026 that its Committee for Medicinal Products for Human Use (CHMP) recommended 5 new drugs for approval at its March 2026 meeting.1 These approvals were for treatments of cancers, activated phosphoinositide 3-kinase delta syndrome, and different types of oedemas. CHMP also recommended extending the indication of 13 medicines and confirmed its rejection of a change for tasimelteon.

What Were the 5 Approval Recommendations?

CHMP granted conditional marketing authorization to Adstiladrin (nadofaragene firadenovec), for the treatment of adult patients with Bacillus Calmette-Guérin unresponsive non-muscle invasive bladder cancer with carcinoma in situ with or without papillary tumors.

Two lung cancer treatments were recommended: a new treatment for relapsed extensive-stage small cell lung cancer (ES-SCLC), Imdylltra (tarlatamab), addresses an unmet need for adults with limited treatment options; and a maintenance treatment, Zepzelca (lurbinectedin), for patients with (ES-SCLC) whose disease has not progressed after first-line induction therapy.

Imdylltra (tarlatamab) is a monotherapy to adults with ES-SCLC that has relapsed during or after initial treatment with platinum-based chemotherapy. The treatment options for these patients are limited.2 Tarlatamab is a bispecific antibody that acts as a T-cell engager that binds to the DLL3 protein on tumor cells and the CD3 protein on T cells, activating T cells and leading to the production of inflammatory cytokines and the release of cytotoxic proteins. This leads to tumor cell death. Results from a phase 3 study showed significant improvement in median overall survivor rate of 13.6 months in patients treated with Imdylltra compared to 8.3 months with the usual standard of care.2

A positive opinion was granted under exceptional circumstances to Joenja (leniolisib), for the treatment of the rare, inherited condition, activated phosphoinositide 3-kinase delta syndrome (APDS) in adults and adolescents 12 years of age and older and weighing 45 kg or more. APDS is a progressive condition of the immune system that may be life threatening.

Pediatric-use marketing authorization was given to Bopediat (furosemide) for the treatment of cardiac or renal oedema as well as hepatic oedema and hypertension in children from birth to under 18 years of age with chronic kidney disease. The product’s sponsor submitted a hybrid application that relies on pre-clinical tests results and clinical trial results of an already-authorized reference product as well as new data.

What other decisions did CHMP make?

CHMP recommended extensions for the following 13 drugs:

Besponsa
Capvaxive
Feraccru
Hetronifly
Hympavzi
Imcivree
Lojuxta
Mekinist
mResvia
Namuscla
Retsevmo
Sotyktu
Tafinlar.

However, the committee, after reexamination, refused to change the marketing authorization for Hetlioz (tasimelteon) to include the treatment of nighttime sleep disturbance in adults and children aged 3 to 15 years with Smith-Magenis syndrome.

CHMP also finalized its review of the antiviral, Tecovirimat SIGA (tecovirimat), to treat smallpox, mpox, and cowpox.3 The committee concluded that Tecovirimat SIGA should not be used to treat mpox, a viral infection that can lead to serious illness in children, pregnant people, and those with weakened immune systems. The recommendation was in response to data from 4 studies that showed Tecovirimat SIGA did not heal lesions faster, relieve pain, or clear the virus from the body faster when compared to a placebo.

“At the time of approval, it was not possible to carry out studies in infected people, as the viruses rarely circulated,” EMA stated in a press release.3 “Therefore, the approvals of Tecovirimat SIGA for mpox, as well as for smallpox, cowpox and complications from smallpox vaccines, were based on results from an animal model of mpox infection. The animal data demonstrated antiviral activity and a survival benefit when treatment was started early and a reduced efficacy if treatment was initiated later after exposure to the virus.”

Additional data on the benefits and risks of Tecovirimat SIGA were considered from programs in the United States and Africa, a epidemiological study in the European Union, animal studies, laboratory data, and published scientific research. The review did not identify any new safety concerns.

References

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 23-26 March 2026. EMA. Press Release. March 27, 2026. Accessed March 30, 2026. https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-23-26-march-2026
New treatment for relapsed extensive-stage small cell lung cancer. EMA. Press Release. March 27, 2026. Accessed March 30, 2026. https://www.ema.europa.eu/en/news/new-treatment-relapsed-extensive-stage-small-cell-lung-cancer
EMA recommends restricting use of Tecovirimat SIGA. EMA. Press Release. March 27, 2026. Accessed March 30, 2026 https://www.ema.europa.eu/en/news/ema-recommends-restricting-use-tecovirimat-siga