FDA approves treatment of metastatic small cell lung cancer
The U.S Food and Drug Administration (FDA) has approved lurbinectedin (Zepzelca) for the treatment of adult patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy, according to a press release from Jazz Pharmaceuticals.
The drug was granted accelerated approval based on data showing overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial, according to the company.
“Small cell lung cancer is a disease with limited treatment options, and the approval of Zepzelca represents an important advance for patients whose metastatic SCLC has progressed on or after platinum-based therapy,” said Bruce Cozadd, chairman and CEO of Jazz Pharmaceuticals in a statement. “While patients may initially respond to traditional chemotherapy, they often experience an aggressive recurrence that is historically resistant to treatment. Jazz congratulates PharmaMar on the successful development of Zepzelca and we are proud to partner with them to bring this new therapy to the U.S. market, expanding our presence in oncology.”
Read the full press release here.