The US Food and Drug Administration (FDA) has approved a new combination therapy by Jazz Pharmaceuticals and Roche as a maintenance treatment for adults with extensive-stage small cell lung cancer (ES-SCLC) whose disease has not progressed after initial chemotherapy.
The newly approved regimen combines Jazz’s Zepzelca with Roche’s Tecentriq, marking the first and only combination therapy authorized for first-line maintenance treatment of this highly aggressive form of lung cancer. ES-SCLC often spreads rapidly to other parts of the body, including the bone marrow.
“This approval marks the first and only combination therapy for the first-line maintenance treatment of ES-SCLC, a highly aggressive disease for which treatment options have been limited,” Roche said in a statement.
Zepzelca had previously been approved as a second-line treatment option — administered when initial chemotherapy fails. With this latest FDA approval, Jazz Pharmaceuticals confirmed to Reuters that the combination therapy will now be eligible for reimbursement. Zepzelca’s list price stands at $8,110 as of January 14, according to the company, with no change in cost across treatment indications.
The approval follows late-stage clinical trial results showing the combination achieved a 46% reduction in disease progression and a 27% reduction in the risk of death compared with Tecentriq alone.
According to the FDA, the recommended dosing involves Zepzelca administered every three weeks via intravenous infusion, while Tecentriq can be given either intravenously every two to four weeks or subcutaneously every three weeks, depending on the formulation.
Tecentriq, Roche’s widely used immunotherapy, is already approved for multiple cancer types, including non-small cell lung cancer.
In a related development, Amgen’s targeted immunotherapy Imdelltra was approved in May last year as a second-line treatment for patients whose ES-SCLC had progressed after platinum-based chemotherapy.
