FDA Grants Zepzelca Accelerated Approval to Treat Metastatic Small Cell Lung Cancer

The Food and Drug Administration (FDA) on Monday approved Zepzelca (lurbinectedin) for adults with metastatic small cell lung cancer (SCLC) whose disease progressed on or after receiving platinum-based chemotherapy.

"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," Bruce Cozadd, CEO of Jazz Pharmaceuticals, said in a press release. "While patients may initially respond to traditional chemotherapy, they often experience an aggressive recurrence that is historically resistant to treatment.”

The agency gave accelerated approval to the treatment, which can affect the activity of proteins that bind to DNA, resulting in a disruption to the cell cycle and potentially cell death.

The FDA based its decision on the results of an open-label multicenter, single-arm study of 105 patients with platinum-sensitive and -resistant or relapsed SCLC. Data demonstrated that patients who received Zepzelca achieved an overall response rate of 35% and a median duration of response of 5.3 months per assessment by the investigators.

The most common side effects — which occurred in 20% or more of the participants – included:

• fatigue;
• anemia;
• nausea;
• decreased appetite;
• constipation;
• vomiting;
• diarrhea, and
• musculoskeletal pain.

"In addition to the physical toll it takes on patients, a relapse of SCLC also takes a mental and emotional toll on the entire family," Andrea Stern Ferris, president and CEO of LUNGevity, said in the release. "The availability of Zepzelca presents new hope for patients and their loved ones, and we're eager to see its impact on the SCLC community."