South San Francisco, California — October 2, 2025 — Leads & Copy — Genentech, a member of the Roche Group, announced that the FDA has approved Tecentriq® (atezolizumab) and Tecentriq Hybreza® (atezolizumab and hyaluronidase-tqjs) in combination with lurbinectedin (Zepzelca®) for maintenance treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) whose disease has not progressed after first-line induction therapy with Tecentriq or Tecentriq Hybreza, carboplatin and etoposide (CE).
The approval marks the first combination therapy for first-line maintenance treatment of ES-SCLC, a disease with limited treatment options. The NCCN Guidelines® have been updated to include the regimen as a category 2A and preferred option for maintenance treatment of people with ES-SCLC, following induction therapy with Tecentriq and CE.
Roy Herbst, M.D., Ph.D., deputy director and chief of medical oncology and hematology at Yale Cancer Center and Smilow Cancer Hospital, noted the combination provides a proactive approach, improving progression-free and overall survival. Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development, said the company is proud to deliver this advancement for the small cell lung cancer community in partnership with Jazz Pharmaceuticals.
The FDA approval is based on the Phase III IMforte study, which showed the Tecentriq and lurbinectedin combination reduced the risk of disease progression or death by 46% and the risk of death by 27%, compared to Tecentriq maintenance therapy alone. The median overall survival for the Tecentriq plus lurbinectedin regimen was 13.2 months versus 10.6 months for Tecentriq alone (stratified hazard ratio [HR]=0.73; 95% CI: 0.57–0.95; p=0.0174). Median progression-free survival by independent assessment was 5.4 months versus 2.1 months, respectively (stratified HR=0.54; 95% CI: 0.43–0.67; p<0.0001).
Today’s approval builds on Tecentriq’s established role in ES-SCLC, as the FDA approved Tecentriq in combination with chemotherapy for the first-line treatment of adults with ES-SCLC in 2019.
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Source: Genentech
