The U.S. Food and Drug Administration has approved Jazz Pharmaceuticals and Roche's combination therapy as a maintenance treatment for adult patients with a type of lung cancer, the regulator said on Thursday.
Jazz's drug, Zepzelca, in combination with Roche's Tecentriq, is now approved for patients with extensive-stage small cell lung cancer (ES-SCLC), whose disease has not progressed after initial chemotherapy.
This is an aggressive form of lung cancer that may spread 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 is already approved as a second-line treatment - to be administered when the initial treatment fails - for the illness.
"With the FDA approval, the combination will be eligible for reimbursement," Jazz Pharma told Reuters. Zepzelca's list price is $8,110, according to the company website as of January 14. Jazz Pharma noted that the cost does not change per indication.
The combination therapy's approval is based on late-stage trial data showing a 46% reduction in disease progression and a 27% reduction in death risk compared with Tecentriq alone.
The recommended dosing regimen includes Zepzelca given every three weeks by intravenous infusion, and Tecentriq injected either intravenously every two to four weeks, or subcutaneously every three weeks, depending on the formulation, the FDA said.
Roche's Tecentriq is an immunotherapy widely used to treat multiple cancer types, including non-small cell lung cancer.
In May last year, Amgen's targeted immunotherapy, Imdelltra, was approved as a second-line treatment for patients whose disease has progressed after platinum-based chemotherapy.
Jazz's drug, Zepzelca, in combination with Roche's Tecentriq, is now approved for patients with extensive-stage small cell lung cancer (ES-SCLC), whose disease has not progressed after initial chemotherapy.
This is an aggressive form of lung cancer that may spread 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 is already approved as a second-line treatment - to be administered when the initial treatment fails - for the illness.
"With the FDA approval, the combination will be eligible for reimbursement," Jazz Pharma told Reuters. Zepzelca's list price is $8,110, according to the company website as of January 14. Jazz Pharma noted that the cost does not change per indication.
The combination therapy's approval is based on late-stage trial data showing a 46% reduction in disease progression and a 27% reduction in death risk compared with Tecentriq alone.
The recommended dosing regimen includes Zepzelca given every three weeks by intravenous infusion, and Tecentriq injected either intravenously every two to four weeks, or subcutaneously every three weeks, depending on the formulation, the FDA said.
Roche's Tecentriq is an immunotherapy widely used to treat multiple cancer types, including non-small cell lung cancer.
In May last year, Amgen's targeted immunotherapy, Imdelltra, was approved as a second-line treatment for patients whose disease has progressed after platinum-based chemotherapy.
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