Brussels, Belgium. Europe’s medicines regulator has recommended approval of several new treatments, including three cancer therapies, following decisions announced last Friday by the European Medicines Agency (EMA).
Oncology recommendations
The EMA’s Committee for Medicinal Products for Human Use (CHMP) backed tarlatamab (Imdylltra), a new immunotherapy for extensive-stage small cell lung cancer. The announcement said available data show a significant improvement in overall survival compared with existing therapies.
The committee also recommended Zepzelca (lurbinectedin) as a maintenance therapy for small cell lung cancer patients whose disease has not progressed following initial treatment.
A third oncology recommendation covers Adstiladrin (nadofaragene firadenovec), a gene therapy for bladder cancer patients who do not respond to the primary available immunotherapy and who face an elevated risk of disease progression.
Other treatment areas
Beyond oncology, the CHMP issued a positive opinion for Joenja (leniolisib) to treat activated phosphoinositide 3-kinase delta syndrome (APDS), a rare inherited immune disorder that can lead to serious infections and progressive deterioration.
The committee also recommended Bopediat (furosemide) for paediatric use in the treatment of oedema of cardiac, renal or hepatic origin, as well as hypertension in children with chronic kidney disease.
Expanded uses and next steps
The CHMP additionally recommended extended indications for a number of already-approved medicines, broadening their use to new patient groups.
Final marketing authorisation decisions will be taken by the European Commission, after which individual member states will conduct assessments on pricing and reimbursement that will determine when the drugs enter routine clinical practice.
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