FDA granted priority review to Zepzelca plus Tecentriq for first-line maintenance in extensive-stage small cell lung cancer.

Regulatory action was based on data from the Phase III IMforte trial, which showed that Zepzelca plus Tecentriq significantly ...

Jazz Pharma's Zepzelca plus Tecentriq significantly improved survival in a Phase 3 study for extensive-stage small-cell lung ...

Jazz Pharmaceuticals (JAZZ) stock gains as its lung cancer therapy Zepzelca, in combination with Roche's Tecentriq, receives ...

4 ZEPZELCA (lurbinectedin) for injection 4 mg, is indicated for the treatment of adult patients with metastatic SCLC with disease progression on or after platinum-based chemotherapy. This ...

In the Phase III IMforte trial, Tecentriq (atezolizumab) and Zepzelca (lurbinectedin) reduced the risk of disease progression or death by 46% as a first-line maintenance therapy for patients with ...

The sNDA submission was based on findings from the Phase 3 IMforte trial, which showed significant improvements in both progression-free survival (PFS) and overall survival (OS) when Zepzelca was ...

First-line maintenance combination therapy reduced the risk of disease progression or death by 46%, with a median overall survival of 13.2 months vs 10.6 months for atezolizumab alone from the ...

"The FDA's Priority Review designation for Zepzelca in combination with atezolizumab as a first-line maintenance treatment highlights the urgent need for new approaches and the potential benefit ...