CHMP backs Zepzelca plus Tecentriq in ES-SCLC

The European Medicines Agency’s Committee for Medicinal Products for Human Use, or CHMP, has recommended approval of Immedica’s Zepzelca (lurbinectedin) in combination with Roche’s Tecentriq (atezolizumab) as a first-line maintenance treatment for adults with extensive-stage small cell lung cancer whose disease hasn’t progressed after induction with atezolizumab, carboplatin, and etoposide. The recommendation follows results from the phase 3 IMforte trial, which previously showed statistically significant improvements in progression-free survival and overall survival for the combination versus atezolizumab alone in the maintenance setting. CHMP opinions are typically followed by a European Commission decision within about 67 days. (biocentury.com)

Why it matters: For oncology teams, this would add a new EU maintenance option in a disease where relapse is common and durable benefit has been hard to achieve. The regimen has already won FDA approval in the U.S. and has been under NICE review in the UK, suggesting payers, guideline groups, and treatment pathways may now start adapting if the European Commission signs off. (stocktitan.net)

What to watch: The next step is the European Commission’s final decision, followed by country-level reimbursement and access discussions across Europe. (ema.europa.eu)